Adjustable Device Delivery System

ABSTRACT

Herein are described components and use of an adjustable device delivery system including an adjustable internal door which allows angled deployment of medical devices, non-medical devices and electromagnetic radiation. In one embodiment, a slotted outer cannula is used with an inner drive cannula to guide the motion of an adjustable interior door that allows delivery of devices, such as medical instruments, at user-defined angles. The invention also provides device delivery systems that permit withdrawal of the adjustable device delivery system without disruption of a device placed therewith. The device delivery systems of the invention are provided having a steering system that permits exact control of the angle of the adjustable internal door while providing support against longitudinal forces. Also provided are embodiments of the devices of the invention comprising a locking system that provides frictional resistance to overcome unwanted displacement of the door angle and drive system when, for example, manipulation of the device delivery system during its use increases the forces applied to the door surface. The invention further provides methods for using the device delivery systems provided herein for delivering or receiving electromagnetic waves by deflection or reflection of such radiation by the adjustable internal door. The invention also provides methods for steering a device or device delivery system within a confined space.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to the delivery and useful placement ofdevices at angles other than that dictated by the tube geometry. Thisinvention specifically relates to intervention into biological tubes aswell as non-biological systems where placement of a device at an angleis needed in a confined working space.

2. Description of Related Art

The human body contains many tubes of varied sizes, for example, in thecirculatory, digestive, reproductive, respiratory and urologic systems.Numerous devices have been developed to allow inspection andmanipulation of these tubes and surrounding structures. Minimallyinvasive techniques use devices that are externally inserted anddesigned to travel within these tubes. In the vast spectrum of disease,there is often a need to direct, for example, a needle, guidewire,stent, drainage or visualization device at an angle that differs fromthe path of the tube through which the instrument is passed.

Previous descriptions of catheter delivery systems that direct wire-likedevices at angles other than substantially parallel to the pathway ofthe tube through which the delivery system is traveling can be dividedinto either external steerable devices or internal deflection devices.External steerable devices generally consist of long tubes made offlexible materials with a distal end controlled by an internally placedcontrol wire. Traction or tension on the wire causes a torque on thedistal end of the steerable catheter, which causes the distal end to beprojected at an angle different than the proximal end. Hence, the distalend is steered by torque forces formed by pulling on a control wire, andportions of the entire instrument bend toward the direction of theseforces. Internal deflection devices are straight or slightly curvedtubes that have a side port near the distal end that rely on a fixedinternal collision with a fixed internal deflection device. As a wiredevice passes through the tube, it collides with the fixed internaldeflection device and is deflected at a fixed angle out a side port.

Attempts have been made to create functional external steering cathetersas described above. Examples of these devices are described in: U.S.Pat. Nos. 4,582,181, 4,998,917, 5,439,006, and 6,126,649. These devicesshare common weaknesses, the most obvious being that these instruments,when flexed, no longer maintain a low-profile. These devices would notbe able to achieve an adequate degree of angulation inside of a delicatefixed space such as, for example, a blood vessel or other delicatebiological or non-biological space without the danger of accidentallyinjuring or compromising the walls of the space.

As mentioned, these devices generally have a wire that is pulled, whichflexes the delivery system and causes the distal port to project at anangle different than the proximal port. A problem arises with this kindof steerable catheter-type device when the distal tip of the deviceflexes at an angle because such movement can project the distal wall ofthe device outside the narrow passageway of the tube or spaceaccommodating the delivery system. When the distal end of the steerablecatheter is aligned with the proximal end, as it would be for insertion,the device can fit safely inside of a small lumen tube or space.However, as the distal end of the steerable catheter is torqued andconsequently bent at an angle by the tensioning of a control wire ormovement of a steering apparatus, such movement distorts the path andarc of the steerable catheter in such a way that it no longer fitsinside of the small tube or space it was designed to manipulate or inwhich it was designed to operate. That is, as the distal tip or thesteerable catheter is steered, the distal tip is no longer aligned withthe proximal tip. Consequently, a vessel or space that could safelyaccommodate such an instrument would need to be at least as wide as theproximal port, where the instrument is actually inserted, and as wide asthe distal tip when bent at the desired angle for delivery. As asteerable delivery system transforms from a linear tube to a bent tube,sheering forces can place the entire length of the biological tube orthe non-biological space at a high risk of injury. The tip itself, whenturned and projected outside the path of the remainder of the deliverysystem, would generate a high risk of focal perforation.

Attempts have been made to design internal deflecting cannulas.Generally these catheters have side guidewire exit ports locatedproximal to their distal tips. Examples of these devices are describedin U.S. Pat. Nos. 4,405,314, 4,947,864, 5,183,470, 5,190,528, 5,413,581,5,464,395 and 6,511,458. These designs also share common weaknesses.First, internal deflection devices are not adjustable, i.e., deflectioncan be achieved only at one angle. The lack of an adjustable internaldeflection device disallows the use of a guidewire to be used down astraight pathway to place the device in the desired location. Efforts toovercome this weakness by having two separate lumens, one with aninternal deflection device and the other with a straight lumen forplacement of the catheter such as U.S. Pat. No. 5,655,548 are lacking,in part because the need to accommodate multiple lumens doubles thewidth of the delivery system. Such devices are also not adjustable.Moreover, the narrow spaces in which such systems are used limits theangle at which a wire or catheter can be deflected.

Another major weakness shared by both external steerable and internaldeflecting delivery systems is that while deploying a device such as,for example, a stent at an angle is possible, removing the externalsteerable or internal deflecting delivery system with the stent inproper position is exceedingly difficult and impossible at anglesapproaching right-angles to the device passageway. Such problems obviateany practical use of these devices as means of deploying devices, suchas, for example, stents and drainage catheters, at lasting angles.Attempts to remove the external steerable or internal deflectingdelivery system in a linear path, cause collisions between the distalend of delivery system and the delivered device, when placed at an anglethat differs from the linear path of delivery system removal.

The collision problems that arise with removal of external steerabledelivery systems lie in the fact that once a device, such as a stent orwire, has been placed, the delivery system must conform to the shape ofthe lumen or space in order to be removed from the lumen or space. Thatis, as the device is withdrawn along the path of the lumen, the externalshape of the delivery device must conform to the lumen or spacegeometry. Any effort to remove the catheter delivery system in its“bent,” or device delivery, form would cause the distal end, i.e. theend with the deployed device, to deform to the shape of the lumengeometry. Thus any attempts to remove the delivery system with a device,such as a stent or guide-wire, placed at an angle would causedislodgement of the device as the axis of the forces necessary to removethe delivery system differ from the angle of device placement.

Multiple problems arise with removal of internal deflection deliverydevices as well. An obvious problem is seen in U.S. Pat. No. 6,514,217,which relates to an internal deflection device that relies on a flapperassembly to direct a catheter. This assembly uses an internal deflectiondevice just distal to the external slot. Because the internal deflectionof the delivered device must be fixed in a location for a flapper deviceto function, if the operator attempts to remove the internal deflectiondelivery system from the body by pulling proximally along the length ofthe tube, the internal deflection device would collide with the wire orstent, which is projected at an angle different from that of the tube.Consequently, as the delivery system is withdrawn from the body bypulling proximally along the length of the tube, the wire or stent at anangle different from that of the tube would also be pulled along theangle of the tube. This pulling force would tear and disrupt thesurrounding tissues and ultimately the wire or stent would be pulled outof the body along with the delivery system causing great damage.

Thus, external steerable or internal deflection delivery devices havemany limitations inherent in their design leaving a need for a devicethat can fully function in a narrow biological or non-biological space,deploy a variety of separate and lasting devices such as, for example,stents, drainage catheters and visualization devices, at accurate anglesand control these angles of deployment in a user-definable manner. Thesedevices also leave the need for an adjustable device delivery systemthat can be withdrawn from the delivery area after the placement of oneor more devices at a user-defined angle without disruption of thesedevices from their desired location.

SUMMARY OF THE INVENTION

The present invention provides an adjustable device delivery systemcapable of deploying various medical and non-medical devices tobiological and non-biological systems at angles different than the angleof the lumen or space within which the present invention is passed. Thedelivery angle of the devices provided by this invention is alsopreferably different from the angle of the body of the device deliverysystem. The device delivery systems of the invention also permit adelivered device to retain its angle of delivery despite removal of thedevice delivery system. The present invention further provides methodsof utilizing the adjustable device delivery systems of the invention.

In a first aspect, the invention provides an adjustable device deliverysystem comprising an optionally flexible tubular body having a proximalend, a distal end, a longitudinal axis, a lumen extending within thetubular body, and a slot within the tubular body extending to andincluding its distal end; and an adjustable internal door comprising adoor body with a superior, inferior, proximal, distal and two sidesurfaces, one or more door hinge holes in the side surfaces of the doorbody and a door hinge surface on the inferior surface of the door body,the adjustable internal door hingedly coupled to the interior of thetubular body, located opposite the slot in the distal portion of thetubular body. In the adjustable device delivery system of this firstaspect, at least one device can be slidably connected within the lumenof the optionally flexible tubular body, wherein the at least one deviceis deflected off of the proximal surface of the adjustable internal doorat a user-definable angle and delivered to a target site at theuser-definable angle. That is, one or more medical devices, non-medicaldevices or electromagnetic radiation (EMR) emitting and/or receivingdevices can be slidably inserted into, and therefore connected to, thelumen of the adjustable device delivery system of the invention. Onceslidably connected, the at least one device can be slidably moved withinthe lumen in a distal direction until the at least one device collideswith and is deflected off of (or emits radiation that collides with andis deflected off of) the proximal surface of the adjustable internaldoor set at a user-definable angle.

In a second aspect, the optionally flexible tubular body of the firstaspect can comprise an outer cannula and an inner drive cannula, whereinthe inner drive cannula is slidably connected to the inside of the outercannula, optionally on a track system. The distal end of the outercannula can be open, and the distal end of the outer cannula can containa slot extending to and including its distal end. The slot can compriseless than 50 percent of the circumference of the outer cannula or morethan 50 percent of the circumference of the outer cannula. Preferably,the slot comprises about 50 percent of the circumference of the outercannula. Further, the slot can extend more than 3 door-lengths from thedistal end of the outer cannula or less than 3 door-lengths from thedistal end of the outer cannula as well as about 3 door lengths from thedistal end of the outer cannula. The distal portion of the inner drivecannula can comprise an open shaft, which open shaft can approximate thelower portion of a half cylinder.

In a third aspect, the proximal portion of the inner drive cannula ofthe adjustable device delivery system further comprises a drive actuatorto facilitate movement of the inner drive cannula along theproximal-distal, or longitudinal, axis. The drive actuator can furthercomprise a drive barrel with a first diameter (the drive barreldiameter) at the proximal end of the inner drive cannula and a driveshaft with a second diameter (the drive shaft diameter), different thanthe first diameter of the drive barrel, located within the axial lengthof the drive barrel. Where the drive barrel, with its first diameter,and the drive shaft, with its second diameter meet, one or more drivebarrel-drive shaft interfaces, or edges, are created, such that edgesdefined at the one or more drive barrel-drive shaft interfaces provide aleverage means to move the inner drive cannula along the proximal-distalaxis. In such embodiments, the drive actuator can comprise a drivebarrel of a smaller diameter than the drive shaft or a drive barrel of alarger diameter than the drive shaft.

The drive actuator of the adjustable device delivery system of thisaspect can further comprise one or more washers wherein the diameter ofthe hole in the washer (the washer inner-hole diameter) is larger thanthe smaller of the drive barrel diameter or drive shaft diameter butsmaller than the larger of the drive barrel diameter or drive shaftdiameter, wherein the one or more washers can reside on the smallerdiameter drive barrel or drive shaft and press against the largerdiameter drive barrel or drive shaft to move the inner drive cannulaalong the proximal-distal axis. In a related manner, the drive actuatorof the adjustable device delivery system of this aspect can comprise oneor more washers wherein the washer inner-hole diameter is larger thanthe drive barrel diameter but smaller than the drive shaft diameter,wherein the one or more washers can reside on the drive barrel and pressagainst the drive shaft to move the inner drive cannula along theproximal-distal axis. Similarly, the drive actuator of the adjustabledevice delivery system of this aspect can comprise one or more washerswherein the washer inner-hole diameter is larger than the drive shaftdiameter but smaller than the drive barrel diameter, wherein the one ormore washers can reside on the drive shaft and press against the drivebarrel to move the inner drive cannula along the proximal-distal axis.In the above embodiments, the drive barrel and drive shaft can becylindrical.

In a fourth aspect, the outer cannula of the adjustable device deliverysystem of the second and third aspects contains an axle shell toward, ator in its distal end, which axle shell can be located opposite the slotin the outer cannula. The axle shell can hold on its inner surfaces anaxle comprising a middle portion and two cylindrical side portions,wherein the outer diameter of the cylindrical side portions of the axlecorresponds to the inner diameter of the axle shell, and the size andgeometric shape of the middle portion of the axle is the same as ordifferent from the cylindrical side portions of the axle. In theseaspects, the door hinge surface of the adjustable internal door can behingedly coupled to the middle portion of the axle wherein the size andgeometric shape of the middle portion of the axle corresponds to thegeometric size and shape of the inner surface of the door hinge surface.

In a fifth aspect, the adjustable device delivery system of the secondthrough fourth aspects can further comprise a door connector system,comprising one or more door connectors, moveably connecting the distalend of the inner drive cannula at one or more hinge holes to the doorhinge holes in the side surfaces of the door body of the adjustableinternal door. The one or more door connectors comprise a shaft with aproximal and a distal end, the proximal end comprising a proximal innerdrive cannula insertion tab, which is moveably connected to the hingehole in the distal end of the inner drive cannula and the distal endcomprising a distal door insertion tab, which is moveably connected tothe door hinge hole in the side surface of the door body. In theseaspects, proximal movement of the inner drive cannula pulls on the doorconnectors at the proximal inner drive cannula insertion tab andtranslates the proximal movement up the shaft to the distal doorinsertion tab and thence to the door hinge holes on the side surface ofthe adjustable internal door to the door body itself, which hingedlymoves on the axle, increasing the angle of the adjustable internal doorwithin the distal end of the outer cannula. Further, distal movement ofthe inner drive cannula pushes on the door connectors at the proximalinner drive cannula insertion tab and translates the proximal movementup the shaft to the distal door insertion tab and thence to the doorhinge holes on the side surface of the adjustable internal door to thedoor itself, which hingedly moves on the axle, decreasing the angle ofthe adjustable internal door within the distal end of the outer cannula.To facilitate free movement of the adjustable internal door and one ormore door connectors of the above aspects, the distal portions of theouter cannula and the inner drive cannula can be shaped to allow suchfree movement.

In a sixth aspect, the inner drive cannula of the adjustable devicedelivery system of the above aspects is slidably connected to the insideof the outer cannula on a track system, which can comprise an outercannula that contains one or more guide tracks and an inner drivecannula that contains one or more corresponding tracks upon which theinner drive cannula slidably moves on the proximal-distal axis.Likewise, the track system can comprise an outer cannula that containsone or more side guide tracks and/or one or more bottom guide tracks andan inner drive cannula that contains one or more corresponding sidetracks and/or one or more corresponding bottom tracks upon which theinner drive cannula slidably moves on the proximal-distal axis.

In a seventh aspect, the proximal portion of the outer cannula of theabove aspects can be threaded to facilitate the rotatable attachment ofone or more correspondingly threaded attachments. Further, the proximalend of the outer cannula can include a raised ridge of a larger diameterthan the proximal end of the outer cannula.

In an eighth aspect, an attachment of the seventh aspect can comprise asteering assembly comprising a center shaft, two or more cylindricalcutout areas wherein the outer diameter of the drive actuator drivebarrel fits into the inner diameter of the steering assembly centershaft, which shaft is cut out and extends the proximal-distal length ofthe steering assembly, a cylindrical cutout area in the distal end ofthe steering assembly of an inner diameter corresponding to the outerdiameter of the proximal portion of the threaded outer cannula, thecylindrical cutout correspondingly threaded to rotatably attach to theproximal end of the outer cannula enabling proximal-distal movement ofthe steering system, a cylindrical cutout area of an inner diametercorresponding to the outer diameter of the drive actuator drive shaftand a proximal-distal length wherein the cylindrical cutout can fit overa drive actuator drive shaft of larger diameter than the drive actuatordrive barrel or within a detent created when the drive actuator driveshaft diameter is smaller than the drive actuator drive barrel, andwherein the surfaces of the steering assembly correspond to the surfacesof the drive actuator and the outer cannula, whereby the steeringassembly can freely rotate around the longitudinal axes of the driveactuator and the rotational motion of the steering assembly translatesinto proximal and distal translation of the steering assembly inrelation to the outer cannula.

These aspects can further comprise one or more cylindrical slots ofcorresponding diameter and proximal-distal position within the steeringassembly to interact with one or more washers present at the proximalend of the outer cannula and at the diametrically differing interfacesbetween the drive barrel and drive shaft.

In a ninth aspect, the adjustable device delivery system of the aboveaspects can further comprise a lock system comprising an inner surfaceand an outer surface, the inner surface of a diameter corresponding tothe outer diameter of the proximal end of the outer cannula and threadedto facilitate its rotatable attachment to the correspondingly threadedproximal end of the outer cannula. The lock system can lock the positionof the steering assembly, drive actuator, inner drive cannula andadjustable internal door by rotatably butting against the steeringassembly on the threads of the outer cannula preventing the movement ofthe steering assembly, drive actuator, inner drive cannula andadjustable internal door. Likewise, the lock system can unlock theposition of the steering assembly, drive actuator, inner drive cannulaand adjustable internal door by rotatably moving away from the steeringassembly on the threads of the outer cannula enabling the movement ofthe steering assembly, drive actuator, inner drive cannula andadjustable internal door.

In a tenth aspect, the adjustable device delivery system of the aboveaspects can further comprise an outer cannula cover, which outer cannulacover contain an interior tract, wherein the diameter of the outercannula cover interior tract corresponds to the outer diameter of theouter cannula and the outer cannula cover is attached to the proximalend of the outer cannula, the outer cannula residing within the interiortract of the outer cannula cover, and wherein the distal portion of theouter cannula cover can serve as a handle for operation of theadjustable delivery system. In these aspects, the proximal portion ofthe interior tract of the outer cannula cover can be threaded torotatably attach to an outer cannula that is correspondingly threaded atits proximal end. Likewise, the outer cannula cover can be bonded with,for example, an adhesive, to the proximal end of the outer cannula, theouter cannula residing within the interior tract of the outer cannulacover.

In an eleventh aspect, the exterior of the proximal portion of the outercannula cover of the tenth aspect can be threaded to facilitate therotatable attachment of correspondingly threaded attachments. Theproximal end of the outer cannula of these aspects can include a raisedridge of a larger diameter than the proximal end of the outer cannula.Likewise, the raised ridge can be of a diameter equivalent to or largerthan the proximal end of the outer cannula cover. The raised ridge canact as a physical stop for the steering assembly described in earlieraspects.

In a twelfth aspect, the attachment of the eleventh aspect can be asteering assembly comprising a center shaft, two or more cylindricalcutout areas wherein the outer diameter of the drive actuator drivebarrel fits into the inner diameter of the steering assembly centershaft, which shaft is cut out and extends the proximal-distal length ofthe steering assembly, a cylindrical cutout area in the distal end ofthe steering assembly of an inner diameter corresponding to the outerdiameter of the proximal portion of the threaded outer cannula cover,the cylindrical cutout correspondingly threaded to rotatably attach tothe proximal end of the outer cannula cover enabling proximal-distalmovement of the steering system, a cylindrical cutout area of an innerdiameter corresponding to the outer diameter of the drive actuator driveshaft and a proximal-distal length such that the cylindrical cutout canfit over a drive actuator drive shaft of larger diameter than the driveactuator drive barrel or within a detent created when the drive actuatordrive shaft diameter is smaller than the drive actuator drive barrel,wherein the surfaces of the steering assembly correspond to the surfacesof the drive actuator and the outer cannula cover, the steering assemblycan freely rotate around the longitudinal axes of the drive actuator andthe rotational motion of the steering assembly translates into proximaland distal translation of the steering assembly in relation to the outercannula.

These aspects can further comprise one or more cylindrical slots ofcorresponding diameter and proximal-distal position within the steeringassembly to interact with one or more washers present at the proximalend of the outer cannula and outer cannula cover and at thediametrically differing interfaces between the drive barrel and driveshaft.

In a thirteenth aspect, the adjustable device delivery system of theabove aspects can further comprise a lock system comprising an innersurface and an outer surface, the inner surface of a diametercorresponding to the outer diameter of the proximal end of the outercannula cover and threaded to facilitate its rotatable attachment to thecorrespondingly threaded proximal end of the outer cannula cover. Thelock system can lock the position of the steering assembly, driveactuator, inner drive cannula and adjustable internal door by rotatablybutting against, or resting against and in contact with, the steeringassembly on the threads of the outer cannula cover preventing themovement of the steering assembly, drive actuator, inner drive cannulaand adjustable internal door. Likewise, the lock system can unlock theposition of the steering assembly, drive actuator, inner drive cannulaand adjustable internal door by rotatably moving away from the steeringassembly on the threads of the outer cannula cover enabling the movementof the steering assembly, drive actuator, inner drive cannula andadjustable internal door.

In a fourteenth aspect, the adjustable internal door can deflect orfocus electromagnetic radiation. Further, the adjustable device deliverysystem of this aspect can further comprise a means for detectingelectromagnetic radiation deflected, and optionally focused, by theadjustable internal door, the radiation moving in a distal-to-proximaldirection in the adjustable device delivery system.

The devices disclosed in the previously-described aspects of theinvention this comprise a fifteenth aspect, wherein the devices of theinvention comprise an apparatus for delivering a device to a confinedspace, preferably a confined space in an animal body.

In a sixteenth aspect, the invention provides a method of delivering adevice to an confined space comprising the steps of inserting theadjustable device delivery system of the above aspects into the confinedspace; guiding the adjustable device delivery system to a deliverylocation in the confined space for the object to be deployed; orientingthe adjustable device delivery system wherein the slot in the distal endof the outer cannula faces the desired delivery location; adjusting theadjustable internal door to a user-defined angle for delivery of thedevice; delivering the device to the delivery location through the lumenof the adjustable device delivery system tubular body in a proximal todistal direction, wherein the device is deflected off of the adjustableinternal door at about the user-defined angle of the adjustable internaldoor. This aspect of the invention can further comprise the step ofremoving the device delivery system from the confined space with thedevice remaining within the confined space. Alternatively, this aspectof the invention can further comprise the step of removing the devicefrom the confined space along with the device delivery system.

In a seventeenth aspect, the invention provides a method of deploying amedical device at a user-defined angle comprising the steps of insertingthe adjustable device delivery system of the above aspects into a spacethat is connected or proximal to a medical device delivery location;guiding the adjustable device delivery system to the medical devicedelivery location within or proximal to the space; orienting theadjustable device delivery system wherein the slot in the distal end ofthe outer cannula faces the desired direction of medical devicedeployment; adjusting the adjustable internal door to a user-definedangle for delivery of the medical device; and delivering the medicaldevice to the delivery location through the lumen of the adjustabledevice delivery system tubular body in a proximal to distal directionwherein the medical device is deflected off of the adjustable internaldoor at about the user-defined angle of the adjustable internal door.This aspect of the invention can further comprise the step of removingthe device delivery system from the medical device delivery locationwith the medical device remaining within the delivery location whereinthe angle of delivery of the medical device is not altered due topresence of the slot in the distal portion of the tubular body throughwhich the medical device can slide during removal of the device deliverysystem.

In a eighteenth aspect, the invention provides a method of forming apathway between bodily compartments comprising the steps of insertingthe adjustable device delivery system of the above aspects into a firstspace that is proximal to a second space into which the pathway is to beformed; guiding the adjustable device delivery system to a bodilycompartment connection location within the first space; orienting theadjustable device delivery system wherein the slot in the distal end ofthe outer cannula faces the bodily compartment connection location;adjusting the adjustable internal door to a user-defined angle fordelivery of a device that can form a pathway between bodilycompartments; delivering the device that can form a pathway betweenbodily compartments to the bodily compartment connection locationthrough the lumen of the adjustable device delivery system tubular bodyin a proximal to distal direction, wherein the device is deflected offof the adjustable internal door at about the user-defined angle of theadjustable internal door; and forming the pathway between bodilycompartments.

In a nineteenth aspect, the invention provides a method of visualizationin an confined space using electromagnetic radiation comprising thesteps of inserting the adjustable device delivery system of thefourteenth aspect into the confined space; guiding the adjustable devicedelivery system to a visualization location in the confined space;orienting the adjustable device delivery system wherein the slot in thedistal end of the outer cannula faces the desired visualizationlocation; adjusting the adjustable internal door to a user-defined angleto enable deflection of electromagnetic radiation moving in aproximal-to-distal direction from the adjustable device delivery systemto the visualization location and, optionally, back from thevisualization location in a distal-to-proximal direction through thedevice delivery system; delivering the electromagnetic radiation in aproximal-to-distal direction from the adjustable device delivery systemto the visualization location, wherein the electromagnetic radiation isdeflected off of the adjustable internal door at the user-defined angleof the adjustable internal door. The method of this aspect can furthercomprise the step of detecting electromagnetic radiation deflected offof the adjustable internal door, such electromagnetic radiation movingin a distal-to-proximal direction in the adjustable device deliverysystem.

In a twentieth aspect, the invention provides a method of deliveringfocused electromagnetic radiation in an confined space comprising thesteps of inserting an adjustable device delivery system wherein theadjustable internal door can deflect electromagnetic radiation into theconfined space; guiding the adjustable device delivery system to anelectromagnetic radiation target location in the confined space;orienting the adjustable device delivery system wherein the slot in thedistal end of the outer cannula faces the desired electromagneticradiation target location; adjusting the adjustable internal door to auser-defined angle to enable delivery of focused of electromagneticradiation moving in a proximal-to-distal direction from the adjustabledevice delivery system to the electromagnetic radiation target location;and delivering the electromagnetic radiation in a proximal-to-distaldirection from the adjustable device delivery system to theelectromagnetic radiation target location such that the electromagneticradiation is focused by the adjustable internal door and deflected atthe user-defined angle of the adjustable internal door.

In a twenty-first aspect, the invention provides methods of steering adevice or device delivery system within a confined space comprising thesteps of inserting an adjustable device delivery system of the aboveembodiments into the confined space; guiding the adjustable devicedelivery system to a first delivery location in the confined space forthe device to be deployed; orienting the adjustable device deliverysystem wherein the slot in the distal end of the outer cannula faces thefirst delivery location; adjusting the adjustable internal door to auser-defined angle for delivery of the device; delivering the device tothe first delivery location through the lumen of the adjustable devicedelivery system tubular body in a proximal to distal direction whereinthe device is deflected off of the adjustable internal door at about theuser-defined angle of the adjustable internal door; advancing theadjustable device delivery system along the path of delivered device tothe first delivery location; and repeating the above steps to steer thedevice or device delivery system to second, third, fourth deliverylocations and beyond.

In all of the above aspects of the invention, the device delivered bythe adjustable device delivery system can be a medical or non-medicaldevice. Further, the location to which a medical or non-medical deviceis delivered can be in a biological or non-biological system.

Specific preferred embodiments of the invention will become evident fromthe following more detailed description of certain preferred embodimentsand the claims

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of the adjustable device delivery system with atransparent bottom half of the steering assembly.

FIG. 1 a is a top-right isometric view of the adjustable device deliverysystem with a box illustrating the area that is shown in detail in FIG.1 b.

FIG. 1 b is a top-right hidden line view demonstrating distal end ofadjustable device delivery system with the adjustable internal door in aclosed position.

FIG. 1 c is a top-right isometric view of the adjustable device deliverysystem with a box illustrating the area that is shown in detail in FIG.1 d.

FIG. 1 d is a top-right hidden line view demonstrating the proximal endof the adjustable device delivery system with outer cannula cover, orhandle, lock system, drive actuator and steering assembly.

FIG. 2 a is a top-right isometric view of the inner drive cannula with abox illustrating the area shown in detail in FIG. 2 b.

FIG. 2 b is a top-right hidden line view demonstrating the driveactuator on the proximal end of the inner drive cannula that interactswith the steering assembly.

FIG. 2 c. is a top-right isometric view of the inner drive cannula witha box illustrating the area that is shown in detail in FIG. 2 d and FIG.2 e.

FIG. 2 d is a top-right hidden line view demonstrating the distal end ofthe inner drive cannula, which interacts with one or more doorconnectors that comprise the door connector system.

FIG. 2 e is a top-right face view demonstrating the distal end of theinner drive cannula that interacts with one or more door connectors thatcomprise the door connector system.

FIG. 2 f is a bottom-right isometric view of the inner drive cannulawith a box illustrating the area that is shown in detail in FIG. 2 g.

FIG. 2 g. is a bottom-right face view of the distal end of the innerdrive cannula demonstrating how it interacts with the adjustableinternal door and one or more door connectors.

FIG. 2 h is a right view of the inner drive cannula with a boxillustrating the area that is shown in detail in FIG. 2 i.

FIG. 2 i is a side view of the distal end of the inner drive cannulathat demonstrates the attachment location of the one or more doorconnectors and their interaction with the adjustable internal door.

FIG. 2 j is a side view of the inner drive cannula with an isometric boxillustrating the area that is shown in detail in FIG. 2 k.

FIG. 2 k is a front view of the distal end of the inner drive cannula.

FIG. 3 is a cut-away view of the adjustable internal door withoutadditional structures, such as, for example, one or more door connectorsor an axle, which comprises a door body.

FIG. 3 a is a cut-away view of the adjustable internal door from theperspective of looking down the hinge of the door.

FIG. 3 b is a cut-away view of the proximal face of the adjustableinternal door.

FIG. 3 c is a view of the adjustable internal door from the perspectiveof looking down a side surface of the door body.

FIG. 4 is an isometric view of a door connector, one or more of whichcan comprise the door connector system.

FIG. 4 a is a side view of a door connector.

FIG. 4 b is a top view of a door connector.

FIG. 5 is an isometric view of an exemplary axle that hingedly connectsthe door body to the distal portion of the outer cannula.

FIG. 5 a is a side view of an axle.

FIG. 5 b is a top view of an axle.

FIG. 6 is a top-right cut-away view demonstrating the adjustableinternal door, axle, and door connectors.

FIG. 7 is an isometric face view of the outer cannula

FIG. 7 a is an isometric view of the outer cannula with a boxillustrating the area, which is shown in detail in FIG. 7 b.

FIG. 7 b is a top-right cut-away view of the outer cannula demonstratingthe axle shell and slot.

FIG. 7 c is an isometric view of the outer cannula with a boxillustrating the area, which is shown in detail in FIG. 7 d.

FIG. 7 d. is a cut-away front view looking down the distal end of theouter cannula.

FIG. 7 e is an isometric view of the outer cannula with a boxillustrating the area, which is shown in detail in FIG. 7 f.

FIG. 7 f. is a cut-away front view looking down the proximal end of theouter cannula.

FIG. 8 a is a top-right face view of the adjustable internal door, doorconnectors, axle and inner drive cannula demonstrating the interactionof the inner drive cannula and the adjustable internal door in an openposition.

FIG. 8 b is a top-right face view of the adjustable internal door, doorconnectors, axle and inner drive cannula demonstrating the interactionof the inner drive cannula and the adjustable internal door in an about45 degrees closed position.

FIG. 8 c is a top-right face view of the adjustable internal door, doorconnectors, axle and inner drive cannula demonstrating the interactionof the inner drive cannula and the adjustable internal door in a 90degree, or closed, position.

FIG. 8 d is a right side hidden line view of the distal end of theadjustable device delivery system with adjustable internal door in anopen position.

FIG. 8 e is a right-side hidden line view of the distal end of theadjustable device delivery system with an arrow indicating the proximalmovement of the inner drive cannula and its translation, through a doorconnector, to angled movement of the adjustable internal door, here atabout a 45 degree angle.

FIG. 8 f is a right-side hidden line view of the distal end of theadjustable device delivery system with an arrow indicating the proximalmovement of the inner drive cannula and its translation, through a doorconnector, to angled movement of the adjustable internal door, here atabout a 90 degree angle.

FIG. 8 j is a top-right view of an adjustable device delivery systemwith the adjustable internal door in an open, 0 degree position. FIG. 8m shows the same embodiment from an end-view, looking down thelongitudinal axis from the distal end of the adjustable device deliverysystem.

FIG. 8 k is a top-right view of an adjustable device delivery systemwith the adjustable internal door in a partially closed, 45 degreeposition. FIG. 8 n shows the same embodiment from an end-view, lookingdown the longitudinal axis from the distal end of the adjustable devicedelivery system.

FIG. 8 l is a top-right view of an adjustable device delivery systemwith the adjustable internal door in a closed, 90 degree position. FIG.8 o shows the same embodiment from an end-view, looking down thelongitudinal axis from the distal end of the adjustable device deliverysystem.

FIG. 8 m is a cut away view of the adjustable internal door, doorconnectors, and inner drive cannula, looking distally down the innerdrive cannula to demonstrate the clear pathway down the lumen of theadjustable device delivery system when the door is in an open position.

FIG. 8 n is a cut away view of the adjustable internal door, doorconnectors, and inner drive cannula, looking distally down the innerdrive cannula to demonstrate the partially blocked longitudinal pathwaydown the lumen of the adjustable device delivery system when the door isin a 45 degree position.

FIG. 8 o is a cut away view of the adjustable internal door, doorconnectors, and inner drive cannula, looking distally down the innerdrive cannula to demonstrate the blocked longitudinal pathway down thelumen of the adjustable device delivery system when the door is in aclosed, 90 degree position.

FIG. 9 is a top-right isometric view of the adjustable device deliverysystem with an isometric box illustrating the area, which is shown indetail in FIG. 9 b.

FIG. 9 b is a cut-away front view looking distally down the longitudinalaxis of the adjustable device delivery system demonstrating an exemplaryfit of an inner drive cannula in an outer cannula.

FIG. 9 c is a top-right isometric view of the adjustable device deliverysystem with an isometric box illustrating the area, which is shown indetail in FIG. 9 d.

FIG. 9 d is a cut-away view demonstrating an exemplary fit of theadjustable internal door in relation to the inner drive cannula and theouter cannula when said door is closed at a 90 degree position.

FIG. 9 e is a top-right isometric view of the adjustable device deliverysystem with an isometric box illustrating the area, which is shown indetail in FIG. 9 f.

FIG. 9 f is a cut-away view demonstrating an exemplary fit of theadjustable internal door in relation to the inner drive cannula and theouter cannula when said door is open at a 0 degree position.

FIG. 10 a is a top-right cut-away view of an exemplary outer cannulacover.

FIG. 10 b is a front view of an outer cannula cover.

FIG. 10 c is a side view of an outer cannula cover.

FIG. 10 d is a view of an exemplary washer that can be placed at theinterface between the drive actuator at the proximal end of the innerdrive cannula and the steering system.

FIG. 10 e is a view of an exemplary washer that can be placed betweenthe outer cannula cover and the distal interior edge of the steeringsystem.

FIG. 11 a is an isometric view of the proximal portion of the adjustabledevice delivery system, including an inner drive cannula, outer cannula,and outer cannula cover, with a box illustrating the area, which isshown in detail in FIG. 11 b.

FIG. 11 b is a top-right view that demonstrates an exemplary fit of aninner drive cannula and an outer cannula in relation to an optionalouter cannula cover.

FIG. 11 c is a side view of the proximal portion of the adjustabledevice delivery system, including an inner drive cannula, outer cannula,and outer cannula cover, with a box illustrating the area, which isshown in detail in FIG. 11 d.

FIG. 11 d is a side view that demonstrates an exemplary fit of an innerdrive cannula and an outer cannula in relation to the optional outercannula cover.

FIG. 11 e is a side view of the proximal drive system with a boxillustrating the area, which is shown in detail in FIG. 11 f.

FIG. 11 f is a side hidden-line view of the proximal portion of theadjustable device delivery system, including an inner drive cannula, theproximal portion of which comprises a drive actuator, outer cannula, andan outer cannula cover, with a cutaway view of half of the steeringassembly also shown. An exemplary relationship between the steeringassembly and the drive actuator can be seen, wherein, in this example,the drive actuator comprises washers at the interface between steeringassembly and the drive actuator.

FIG. 11 g is a side hidden-line view of the proximal portion of theadjustable device delivery system including an exemplary relationship ofcorrespondingly threaded surfaces of the outer cannula cover (when used)and the steering assembly.

FIG. 12 a is an isometric view of the adjustable device delivery systemwith an isometric box illustrating the area that is shown in detail inFIG. 12 b.

FIG. 12 b is a top-right hidden-line view of a steering assembly.

FIG. 12 c is an isometric view of the adjustable device delivery systemwith a box illustrating the area, which is shown in detail in FIG. 12 d.

FIG. 12 d is a top-right cut-away view of the steering assembly whichprojects motion of the related drive actuator on the proximal end of theinner drive cannula when the steering assembly is rotated.

FIG. 12 e is a hidden-line side view of the proximal portion of theadjustable device delivery system demonstrating the steering apparatustoward the distal end of its motion, in this example corresponding to anopen door position of about 0 degrees.

FIG. 12 f is a hidden-line side view of the proximal portion of theadjustable device delivery system demonstrating the steering apparatustoward the proximal end of its motion, in this example corresponding toa closed door position of about 90 degrees.

FIG. 12 g is a hidden-line side view of the proximal portion of anexemplary adjustable device delivery system demonstrating the steeringapparatus when the adjustable internal door is in the open position anda lock system is in an open, unlocked position.

FIG. 12 f is a hidden-line side view of the proximal portion of anexemplary adjustable device delivery system demonstrating the steeringapparatus when the adjustable internal door is in the open position anda lock system is in a closed, locked position.

FIG. 13 a is an isometric view of the adjustable device delivery systemwith a box illustrating the area, which is shown in detail in FIG. 14 b.

FIG. 13 b is a top-right face view of an exemplary outer cannula cover,or handle.

FIG. 14 a is an isometric view of an adjustable device delivery systemwith a box illustrating the area, which is shown in detail in FIG. 15 b.

FIG. 14 b is a top-right face view of an exemplary lock system.

FIG. 15 a is a view of a vessel and a collection in need of draininglocated superior to the vessel and at an angle to the vessel lumen.

FIG. 15 b shows a guidewire placed down the vessel lumen.

FIG. 15 c shows the adjustable device delivery system slid into positionnext to the collection using the guidewire, with the adjustable internaldoor in an open position.

FIG. 15 d shows the adjustable device delivery system in position afterthe guidewire has been removed.

FIG. 15 e shows a device, such as an intravascular ultrasound, passeddown the lumen of the adjustable device delivery system.

FIG. 15 f shows the user-defined angulation of the door directing thetip of the ultrasound device such that the desired target can bevisualized.

FIG. 15 g shows the angulation of the door used to deflect the energywaves of a visualization device such as an intravascular ultrasound.

FIG. 15 h shows the adjustable internal door locked in position afterthe ultrasound device has been removed.

FIG. 15 i shows a device, for example a needle, that ahs been placeddown the adjustable device delivery system, deflected at the angledefined by the adjustable internal door and delivered into the targetlumen or space.

FIG. 15 j shows a drainage catheter slid over the needle so that it canconnect the two vessels.

FIG. 15 k shows the drainage catheter after the needle has been removed.

FIG. 15 l shows the drainage catheter in the same position with theadjustable internal door in a fully opened position.

FIG. 15 m shows the adjustable device delivery system being removed fromthe lumen without disrupting the placement of the drainage catheter.

DETAILED DESCRIPTION OF THE INVENTION

This invention provides an adjustable device delivery system capable ofdeploying various medical and non-medical devices to biological andnon-biological systems at angles different from the angle of the lumenor space within which the present invention is passed. The deliveryangle of the devices of the invention is also preferably different fromthe angle of the body of the device delivery system. The device deliverysystems of the present invention advantageously permit a delivereddevice to retain its angle of delivery despite removal of the devicedelivery system. The present invention also provides methods ofutilizing the adjustable device delivery systems of the invention.

As used herein, the words “longitudinal” and “proximal-distal” and thelike describe the long axis of the adjustable device delivery system ofthe invention. For example, “longitudinal movement” or “proximal-distalmovement” generally describes movement in either direction along thelong axis of the adjustable device delivery system of the invention.Embodiments that are referred to as “proximal” are located nearer theend of the adjustable device delivery system that comprises, forexample, the steering assembly. Embodiments that are referred to as“distal” are located nearer the end of the adjustable device deliverysystem that comprises, for example, the slot and the adjustable internaldoor. Likewise, “proximal” movement refers to movement of, for example,a medical device within the adjustable device delivery system of theinvention toward the end that comprises the steering assembly. “Distal”movement refers to movement in the direction opposite proximal movement,i.e. toward the end of the adjustable device delivery system thatcomprises, for example, the slot and the adjustable internal door.

As used herein, the words “corresponding,” “correspondingly,”“complementary,” and the like, describe embodiments that operablyinteract. For example, a bolt and a matching nut that operably interact,i.e., “screw together,” would be referred to herein as being“correspondingly threaded” or having “complementary threads” or“complementary surfaces,” and the like.

As used herein, the word “confined,” “confined space,” and the like,describe spaces that are generally not easily or readily accessible, forexample, in the lumen of a blood vessel in a biological system, intowhich a medical, non-medical or EMR device need be delivered. Theadjustable device delivery system of the invention can also be utilizedin easily accessible, unconfined spaces.

The invention is now particularly described with reference to thedrawings, which are provided herein to facilitate appreciation ofcertain aspects of the invention but which are not limiting to the scopeof the appended claims.

FIG. 1 is a side shaded view of an embodiment of the adjustable devicedelivery system of the invention. The inventive catheter componentsinclude an outer cannula (146; synonymous with outer cannula shaft) ofany suitable length, an inner drive cannula (140), an outer cannulacover that can optionally be used as a handle (124), a steering assembly(120), a lock system (122), and an adjustable internal door (104) thatrotates in relation to the outer cannula by use of an axle (144)assembly.

Advantageously, the outer cannula is slotted (130) at its distal end,which slot has a proximal end and a distal end. In preferredembodiments, the proximal end of the slot starts proximal to theadjustable internal door and continues to the distal end of the outercannula (182). In preferred embodiments, the distal end of the slot andthe distal end of the outer cannula coincide. The location of the slotis illustrated in FIG. 1 a. FIG. 1 b shows the assembly in more detailand demonstrates the adjustable internal door assembly. The adjustableinternal door (104) is preferably located inside of the outer cannula(146), between the proximal end of the slot in the outer cannula (130)and the distal end of the outer cannula (182). The adjustable internaldoor can be connected to the outer cannula opposite the distal cut awayslot (130) by means of a door hinge (208) connected to an axle (144)that resides in an axle shell (128), which can be embedded in theinterior surface of the outer cannula (188). This adjustable internaldoor assembly allows the door one degree of freedom wherein the door canhingedly move from an open position in which the door lies parallel tothe longitudinal axis of the outer cannula to a closed position in whichthe door sits perpendicular to the longitudinal axis of the outercannula.

The adjustable internal door (104) has hinge holes in its outer edges(152), which are analogous to hinge holes in the distal end of the innerdrive cannula (154). These hinge holes are the sites of insertion forthe insertion tabs on the proximal and distal ends of one or more doorconnectors (108). The interior surface of the outer cannulaadvantageously can have cut-away slots to accommodate the inner drivecatheter and the movement of the adjustable internal door, axle,connector elements, and any means by which the adjustable internal doorhingedly moves without collision. Item (148) represents a side guidetrack on which the inner drive cannula can slide. Tracks on the innerdrive cannula can fit into corresponding guide tracks in the outercannula. The guide track and corresponding track elements comprise atrack system that facilitates proximal-distal motion of the inner drivecannula within the outer cannula. Item (158) demonstrates the distaledge of a cut-away track allowing unobstructed movement and rotation ofthe one or more door connectors.

FIG. 1 d illustrates in detail the structures shown in FIG. 1 c. FIG. 1d demonstrates the proximal end of the adjustable device delivery systemof the invention. The shafts of the outer cannula (146) and inner drivecannula (140) can fit inside of an outer cannula cover assembly, orhandle. The inner drive cannula slides proximally and distally guided bythe guide track inside of the outer cannula. The outer catheter cover,or handle assembly, can include a surrounding handle cover (132) and anoperator handle surface (124). The steering assembly (120) is alsoillustrated. The steering assembly controls proximal and distal movementof the inner drive cannula in relation to the outer cannula through itsinteraction with the steering actuator. A series of washers (114) canoptionally be present that surround the drive shaft (142) of theproximal end of the inner drive cannula to ensure that rotationalmovement of the steering system (120) is not translated as torque to theinner or outer cannulas. Medical devices, such as, for example,guidewires or stents, or non-medical devices can be inserted through theproximal end of the inner drive cannula (160) into the interior shaft(136). These instruments pass down the barrel of a preferablycylindrical surface. The two halves of the generally cylindricalpassage-way are formed by the superior interior portion of the outercannula and the interior superior portion of the inner drive cannula(shown in FIG. 9 b ELEMENT 168) in a straight path (170). When the dooris in a 90 degree position relative to the longitudinal axis of theouter cannula, the medical or non-medical devices will be deflected atan about 90-degree angle off the proximal face of the door (FIG. 1 bELEMENT 212) and out the cut-away slot of the outer cannula (FIG. 1 bELEMENT 130). When the door is in an open, 0-degree position, medicaland non-medical devices can pass straight down the path (170),unobstructed, and pass out the distal end of the outer cannula (FIG. 1 bELEMENT 182).

Inner Drive Cannula

The box in FIG. 2 a provides a proximal view of the inner drive cannula.FIG. 2 b shows the proximal end of the inner drive cannula in detail.While the distal portion of the shaft of the inner drive cannula (140)is not a complete cylinder, i.e., an “open shaft”, the drive barrel(166) is cylindrical and does not have an outer cutaway surface. Thedrive barrel (166) connects to an enlarged drive shaft (142).Alternatively, the drive shaft can be of a smaller diameter than thedrive barrel. The drive shaft and/or drive barrel interacts with thesteering assembly, optionally via a system of washers. Preferably, thefirst washer lies flush on the proximal surface of the drive shaft (162)while the second is located flush to the distal surface (164). Where thedrive shaft is of a smaller diameter than the drive barrel and washersare present, the first washer lies flush at the proximal interface ofdifferent radii between the drive barrel and the drive shaft and thesecond washer is positioned at the distal interface of different radiibetween drive barrel and drive shaft. The drive barrel (166), driveshaft (142) and, optionally, washers comprise the drive actuator, whichis located at the proximal end of the inner drive cannula. The driveactuator can be directly associated, or in contact, with the proximalend of the inner drive cannula or indirectly associated, for example,through one or more intermediate elements. For example, the driveactuator and inner drive cannula can interact through a set of gears toincrease or decrease the longitudinal movement of the steering assemblyor through a compressible member, like an elastomer, to elasticallytransmit the longitudinal force of the steering assembly to theadjustable internal door at the distal end of the inner drive cannula.In these embodiments, a medical or non-medical device inserted into theproximal opening (136) at the proximal end of the inner drive cannula(160) is advanced by a user or a machine down the drive barrel (166) anddrive shaft (142) and continues distally (170), to the adjustableinternal door, where it later interacts therewith.

The box in FIG. 2 c illustrates a distal view of the inner drivecannula, and FIG. 2 d illustrates a hidden line view of the distalportion of the shaft (140) of the inner drive cannula. The distal shaftis not necessarily a complete cylinder but can approximate the lowerhalf of a cylinder with a superior internal face (168) that is shaped toallow the inferior path (170) of an inserted medical or non-medicaldevice.

The distal portion of the inner drive cannula is further illustrated inFIG. 2 e. The inner drive cannula can have cut-away surfaces toaccommodate other parts of the adjustable internal door and the doorconnector system, which is comprised of one or more door connectors. Theinner drive cannula can also include hinge holes (154) that accommodatethe proximal inner drive cannula insertion tab of the door connectors(not shown). Because the adjustable internal door and door connectorsystem do not collide with the outer edge of the inner drive cannula orthe inner edge of the outer cannula, surfaces are cut-away (172) wherenecessary to allow space for the movement of the moving parts at thedistal end of the adjustable device delivery system. Because the bottomedge of the inner drive cannula does not collide with the axle or doorassembly, the bottom edge is cutaway (174) where necessary in similarfashion. The distal edge (150) of the inner drive cannula is rounded toaccommodate these cutaway surfaces.

The box in FIG. 2 f represents the lower-right hand view of the distaledge of the inner drive cannula demonstrated in FIG. 2 g. FIG. 2 gfurther illustrates additional surfaces that can interact with the outercannula. The inner drive cannula can slide forward and backward(proximally and distally) in relation to the outer cannula. The innerdrive cannula can slide within the outer cannula via one or more trackson the side (176) and/or one or more tracks on the bottom (178) locatedon the external surface of the inner drive cannula. Cutaway surfaces onthe distal end of the inner drive cannula (172, 174) can be included tofacilitate proximal-distal movement (i.e., movement along thelongitudinal axis of the outer cannula) of the inner drive cannulawithin the outer cannula. For example, cutaway surfaces can be includedon the distal end of the inner drive cannula to provide space (174)within which an axle or axle shell can slide as the inner drive cannulamoves distally within the outer cannula or space (172) within which oneor more door connectors can move, translating the longitudinal movementof the inner drive cannula within the outer cannula into hinged movementof the adjustable internal door.

The box in FIG. 2 h shows a side view that is shown in further detail inFIG. 2 i. The hinge hole for a door connector (154) can be locatedproximal to the distal edge of the inner drive cannula (150). The innerdrive cannula can slide in a proximal-distal direction, optionally, onone or more side tracks (176) and/or one or more bottom tracks (178)that correspond to analogous geometries on the interior surface of theouter cannula, or side guide tracks and bottom guide tracks. The distalend of the inner drive cannula can have cutaway surfaces. For example,in FIGS. 2 h-2 i, cutaway surface 172 and cutaway surface 174 canaccommodate the one or more door connectors and adjustable internaldoor, respectively.

The box in FIG. 2 j illustrates a cut-away front view of the distalportion of the inner drive cannula. The outer surface can be generallycylindrical. However, the inner drive cannula can have projections thatform one or more side tracks (176) and/or one or more bottom tracks(178) to ensure smooth movement inside of the outer cannula. In thisfigure, three surfaces are cut away from this external edge includingthe side (172) cutaways that accommodate the one or more doorconnectors, and the bottom cutaway (174), that accommodates theadjustable internal door. The present invention can also be constructedwithout cutaways for side or bottom tracks or cutaways for one or moredoor connectors and adjustable internal door clearance so long asproximal-distal motion of the inner drive cannula is possible and theangle of the adjustable internal door can be changed in a user-definablemanner. Hinge holes (154) for the proximal inner drive cannula insertiontabs of the door connectors are also shown. In use, the medical ornon-medical device travels down the path (170), wherein the path'sinferior surface is defined by the interior surface (168) of the innerdrive cannula, and the path's superior surface is defined by theinferior surface of the outer cannula (FIG. 9 b; also ELEMENT 168).

Door

FIG. 3 shows a top-right hidden line view of the adjustable internaldoor. The adjustable internal door has a proximal face (212) and adistal face (214). The proximal face (212) can be flat or shaped, forexample, convex shaped, and is responsible for the internal collision ofmedical device, non-medical device or electromagnetic radiation (orwaves; “EMR”) that deflects such device or EMR at the desired angle. Thedistal face (214) can be flat or shaped. Preferably, the distal face isshaped to fit in the device so that its outer geometry approximates theinner geometry of the outer cannula. The distal edge of the door (212)can be curved or flat. Preferably, the distal edge is curved so that itsgeometry corresponds with the outer geometry of the outer cannula whenthe adjustable internal door is in the closed position. The door (152)can accommodate a hole through its width, or one or more holesintroduced in each side that accommodate the insertion of the proximalinner drive cannula insertion tab of one or more door connectors. Theinferior portion of the door (204; or “bottom” with the door at a90-degree angle in relation to the longitudinal axis of the outercannula) comprises a hinge (208) surface and an axle insertion surface(200). The shape of the axle insertion surface can be of any shape butpreferably corresponds to the shape of the middle portion of the axle(FIG. 5 b ELEMENT 262). The superior edge of the adjustable internaldoor (202) can also be curved or straight. If curved, the adjustableinternal door can better avoid external collision between the door andouter cannula.

FIG. 3 a shows a bottom view of the door. This view illustrates one ofthe possible configurations of the proximal (212) and distal (214) facesof the adjustable internal door. The door hinge hole (152) is shown tobe just distal to the proximal face of the door, but can be locatedcloser to the distal edge if desired.

FIG. 3 b shows a front view of the door that would be appreciated whenlooking down the barrel of the adjustable device delivery system in aproximal-to-distal direction with the door closed to a 90-degreeposition. Deflections are made between the inserted medical device,non-medical device or EMR and the front face of the door (212). Thedistance between the door hinge (208) and the superior edge of the door(202) can be constructed so that the door fits exactly inside of theouter cannula. However, such a tight fit is not usually necessary andthe door may be shaped to reflect an imperfect fit. When the door is atabout a 90-degree in relation to the outer cannula, the circumference ofthe door can correspond to the geometry of the outer cannula andgenerally does not project outside of the outer cannula outline.Nevertheless, where the slot in the distal end of the outer cannulacomprises 50 percent or more of the outer cannula circumference, theadjustable internal door can project outside the outer cannula outlinewhen the door is at a 90-degree angle.

FIG. 3 c shows a side view of the door. This view demonstrates anexemplary position of a hinge hole (152) in relation to the proximal(212) and the distal (214) faces of the adjustable internal door. Thedistance between the door hinge hole and the superior edge of theadjustable internal door is also exemplary and the one or more doorhinge holes can be relocated to other locations in the side surfaces ofthe adjustable internal door.

Door Connector System

FIG. 4 shows door connectors consisting of a shaft (250) of any suitableshape, a proximal inner drive cannula insertion tab (254), and a distaldoor insertion tab (252). FIG. 4 a shows a side view of the connectors.The shaft (250) is positioned not to interfere, collide or bind with theinner drive cannula or outer cannula through its longitudinal motion.The inner drive cannula and/or outer cannula can have cutaway surfacesto facilitate the movement of the one or more door connectors. Thelength of the proximal inner drive cannula insertion tab (254) anddistal door insertion tab (252) can correspond to the depth of the hingeholes in the inner drive cannula and door hinge holes in the adjustableinternal door.

Proximal inner drive cannula insertion tab (254) inserts inside of theinner drive cannula hinge hole (FIG. 2 k ELEMENT 154). The length ofinsertion tab (254) should preferably be such that it does not projectpast the superior interior surface of the inner drive cannula (FIG. 2 kELEMENT 168) and into the path of the inserted medical, non-medical orEMR device (FIG. 2 k ELEMENT 170).

Distal door insertion tab (252) fits inside of the door hinge hole (item152, FIG. 3). The length of insertion tab (252) should preferably beless than one half the width of the door so that the two insertion tabsopposite each other do not push on one another. Nevertheless,embodiments comprising a distal door insertion tab that extends beyondhalf the width of the adjustable internal door are contemplated. A topview of the connection system is shown in FIG. 4 b.

Thus the one or more door connectors link the inner drive cannula to theadjustable internal door and translate longitudinal movement of theinner drive cannula within the outer cannula to longitudinal (withrespect to the outer cannula) motion of the superior edge of theadjustable internal door. The adjustable internal door can rotate fromabout 0-degrees, or essentially aligned with the longitudinal axis ofthe adjustable device delivery system to about 90-degrees, orapproximately perpendicular to the longitudinal axis of the adjustabledevice delivery system. In certain embodiments, the adjustable internaldoor can be rotated more than 90 degrees.

More traditional wire or ribbon-based systems, similar to those used tosteer steerable catheter systems (for example, see U.S. Pat. No.6,530,914), are also contemplated for door movement. For example, one ormore manipulation members can attach to the side surfaces of theadjustable internal door, which members can run proximally from theadjustable internal door, through the lumen of the adjustable devicedelivery system to the proximal end, where the user can adjust the angleof the door by exerting pulling or pushing forces on the manipulationmember. Alternatively, the one or more manipulation members can residein one or more lumens separate from the lumen through which the medicaldevice, non-medical device or EMR is delivered.

Axle

An axle is shown in FIG. 5. The axle preferably comprises a cylindricaltube (260) comprising a middle portion and cylindrical side portions.The outer geometry of the middle portion of the axle (262) preferablycorresponds to axle insertion surface (FIG. 3 ELEMENT 200) of theadjustable internal door. Further, the length of the middle portion ofthe axle (262) preferably corresponds to the length of the door hingesurface (FIG. 3 ELEMENT 208). The entire length of the axle preferablyapproximates the length of the cutaway section of the outer cannula axleshell (FIG. 7 d ELEMENT 188). FIG. 5 b shows a top view of the axle andFIG. 5 a shows a side view. In the adjustable device delivery systems ofthe invention, the side cylindrical surfaces of the axle can also rotateon bearings that reside in the axle shell.

Door Assembly

FIG. 6 shows an adjustable internal door body, i.e., a door withoutattachments such as an axle or door connectors, along with two doorconnectors and an axle attached in one exemplary position. One or moredistal door insertion tabs (252) fit inside one or more door hinge holes(152) and one or more proximal inner drive cannula insertion tabs (254)fit inside of one or more hinge hole on the distal portion of the innerdrive cannula (FIG. 2 k ELEMENT 154). The middle portion of the axle(262) inserts inside the door hinge surface (208). The cylindrical sideportions of the axle (260) fit into the axle shell (FIG. 7 d ELEMENT128), such that the adjustable internal door can rotate withoutcolliding with the inner drive cannula or the outer cannula.

Outer Cannula

FIG. 7 shows a top-right view of the outer cannula. The outer cannula isgenerally a cylinder with a proximal end (180), a distal end (182), witha hollow shaft (146) extending between the proximal end and distal end,an inner surface, an outer surface and a circumference. The distal endof the outer cannula (182) can have a portion of its circumference cutaway to form a slot (130). The size of the slot, both the longitudinallength and the percentage of the circumference removed, can be variedbased on the needs of the user or procedure. As an example, the slot canbe approximately three door-lengths in length. The adjustable internaldoor can be located beneath the slot, such that when the door isadjusted to about a 90-degree angle in relation to the longitudinal axisof the outer cannula, the slot extends proximally from the superiorsurface of the adjustable internal door. For example, the slot canextend approximately one and one-half door lengths proximal to the axleshell (FIG. 7 b ELEMENT 128) and extend to the distal end of the outercannula (182). The slot (130) can comprise more than 50 percent of thecircumference or less than 50 percent of the circumference, as well asabout 50 percent of the circumference.

The box in FIG. 7 a shows the location of the view that is shown indetail in FIG. 7 b. FIG. 7 b shows a top-right hidden-line view of thedistal portion of an exemplary outer cannula. The slot (130) is shownextending to the distal end of the outer cannula (182). An exemplarylocation of the axle shell (128) is also demonstrated. The axle shell(128) is located on the bottom interior surface of the outer cannula andis on the opposite side of the slot (130). The axle shell can also belocated at the distal end of the outer cannula wherein when the door isin an open position, parallel to the longitudinal axis of the outercannula, the distal end of the door projects beyond the distal end ofthe outer cannula. The axle shell (128) is hollow with a cylindrical cutaway area (188), which permits the cylindrical side portions of the axle(FIG. 5 ELEMENT 260) to insert and rotate freely.

FIG. 7 b also shows portions of exemplary interior geometry for an outercannula. Side guide tracks (148) accommodate the side tracks of theinner drive cannula (FIG. 2 k ELEMENT 176). The outer cannula is alsoshown with a bottom guide track (184) into which the bottom track of theinner drive cannula (FIG. 2 k ELEMENT 178) fits.

The box in FIG. 7 c shows the distal location on the outer cannula ofthe front cut-away view shown in FIG. 7 d. The outer geometry of thisexemplary outer cannula shaft (146) is cylindrical. In alternateembodiments, the outer cannula can be a non-cylindrical shape. Anexemplary slot (130) is shown at the top portion of the figure, herecomprising less than 50 percent of the outer cannula circumference. Sideguide tracks (148), when present, guide the movement of the of the innerdrive cannula by rotationally interlocking with the side tracks, whilestill allowing free longitudinal movement. Likewise, one or more bottomguide tracks (184) of the outer cannula, when present, accomplish thesame purpose, guiding the longitudinal movement of the inner drivecannula via its one or more bottom tracks. An axle shell (128) withhollow cut away area (188) is shown with its position opposite the outercannula slot. Exemplary items (158) demonstrate that the interiorsurface of the outer cannula can be cut-away, if necessary, to allow forthe fit of the door connection system and the adjustable internal door'sunobstructed movement. In some embodiments, the distal end of the innerdrive cannula can also be cut-away, or have cut-away surfaces, to allowfor the fit of the door connection system and the adjustable internaldoor's unobstructed movement.

The box in FIG. 7 e shows the proximal location on the outer cannula ofthe detailed front view of FIG. 7 f. This view corresponds to oneobtained by looking distally down the barrel of the outer cannula. Inthis example, the demonstrated outer cannula geometry could extend fromthe proximal surface of the outer tube (180) until the beginning of thesift area (130), after which the distal geometry of the outer tube couldcorrespond to geometry that is shown in FIG. 7 d. FIG. 7 f demonstratesthe same optional side and bottom guide tracks for side (148) and bottom(184) tracks on the inner drive cannula. The primary difference betweenthe geometry in FIG. 7 d and FIG. 7 f is that in FIG. 7 f, the topportion of the outer cannula does not include the slot. The exterior topedge of the proximal outer cannula corresponds to the cylindrical shapeof the outer cannula shaft (146). The interior geometry of the superiorsurface of the proximal portion of the outer cannula (168) is theequivalent to the geometry that was dictated by the superior interiorsurface of the distal portion of the inner drive cannula (FIG. 2 kELEMENT 168). Thus, as an example, the superior interior geometry of theouter tube can approximate the top half of an equivalent cylinder, sothat when the inner drive cannula is placed inside of the outer cannula,the combined interior surfaces (168) can comprise a complete cylinder(FIG. 9 b).

The outer cannula can be, for example, threaded to accommodate theattachment of a correspondingly threaded outer cannula cover, or handle,as well as other attachments. An exemplary attachment is a steeringassembly.

Door Motion in Relation to Cannulas

FIGS. 8 a, 8 b, and 8 c are top right surface views of the inner drivecannula (140), adjustable internal door (104), axle (144), and doorconnectors (108). The three exemplary views correspond to the relationof the elements when the door is at about 0 degrees, about 45 degrees,and about 90 degrees. The axle (144) is free to rotate but is fixed inthe longitudinal direction inside of the axle shell (FIG. 7 b ELEMENT128) located in the outer cannula. As the inner drive cannula is pulledproximally (to the bottom left side of the illustration), the doorconnectors pull the adjustable internal door at the door hinge holes(152). This longitudinal motion rotates the angle of the door as isshown in FIG. 8 a through FIG. 8 c. Such longitudinal motion of thesuperior edge of the adjustable internal door is possible in partbecause the door connectors are free to rotate in both the hinge holes(154) of the inner drive cannula and door hinge holes (152).

FIGS. 8 d, 8 e, and 8 f are right side hidden line views of the innerdrive cannula (140), adjustable internal door (104), axle (144), anddoor connectors (108). The three exemplary views correspond to therelation of the elements when the door is at about 0 degrees, about 45degrees, and about 90 degrees. When the distal surface (150) of theinner drive cannula (140) is pulled proximally (away from the distal endof the outer cannula and to the left side of the illustration), force isapplied to the adjustable internal door (104), which changes the angleof the adjustable internal door accordingly. The axle (144) is free torotate but is fixed in the longitudinal direction inside the axle shell(128). That is, although the axle can rotate, its position in relationto the outer cannula does not change.

FIGS. 8 g, 8 h, and 8 i are top right surface views of the outer cannula(146), the slot (138) in the outer cannula, the inner drive cannula(140), adjustable internal door (104), and door connectors (108). Thethree exemplary views correspond to the relation of the elements whenthe door is at about 0 degrees, about 45 degrees, and about 90 degrees.The arrows on FIG. 8 h and FIG. 8 i are shown to indicate the proximalmovement of the inner drive cannula in relation to the distal end of theouter cannula as the door angle changes from about 0 degrees (FIG. 8 g)to about 90 degrees (FIG. 8 i).

FIGS. 8 j, 8 k and 8 l are right side views of the inner drive cannuladrive (140), adjustable internal door (104), axle (144), and doorconnectors (108). The position of the adjustable internal door in FIGS.8 j, 8 k and 8 l corresponds to the position of the door in thelongitudinal views of FIGS. 8 m, 8 n and 8 o, respectively. FIGS. 8 j, 8k and 8 l include exemplary relative positions of the proximal innerdrive cannula insertion tabs (FIG. 4 a, ELEMENT 254) and distal doorinsertion tabs of the door connector elements (FIG. 4 a; ELEMENT 252).FIGS. 8 m, 8 n, 8 o represent a front view of a cut away portion of theinner drive cannula, looking distally, having a view that would beexperienced by a medical or non-medical device passing down the barrelof a adjustable device delivery system of the invention. FIG. 8 m showsthe door in an open, 0 degree position (i.e., parallel to thelongitudinal axis of the outer cannula). In this exemplary embodiment,the path of the medical or non-medical device passing through theadjustable device delivery system would pass to the distal end of theouter cannula unobstructed. FIG. 8 n shows the door in an about 45degree position. In such an instance, the path of the medical ornon-medical device passed through the adjustable device delivery systemis deflected at about a 45 degree angle from the longitudinal axis ofthe device delivery system. FIG. 8 o shows the door in about a 90 degreeposition (i.e., perpendicular to the longitudinal axis of the outercannula). In such an instance, the path of the medical or non-medicaldevice passed through the adjustable device delivery system is deflectedat about a right angle from the longitudinal axis of the of the devicedelivery system.

Door Geometry in Relation to Outer and Inner Drive Cannulas

FIG. 9 a is a top right view of the adjustable device delivery systemwith a box indicating the location of the cut-away view shown in FIG. 9b. FIG. 9 b shows an exemplary relationship of the surfaces of the innerdrive cannula and the outer cannula. The medical device, non-medicaldevice or EMR passes down the barrel or lumen of the adjustable devicedelivery system (170) with a path defined by the cylindrical geometry ofthe superior surface of the inner drive cannula (168) and the exteriorinferior surfaces of the outer cannula (168). A side track of the innerdrive cannula (176), if present, fits inside the corresponding sideguide track of the outer cannula (148). A bottom track of the innerdrive cannula (178), if present, fits inside a corresponding bottomguide track (184) of the outer cannula.

FIG. 9 c is a top right view of the adjustable device delivery systemwith a box indicating the location of a cut-away view shown in FIG. 9 d.FIG. 9 d shows an exemplary fit of the inner drive cannula, outercannula, and adjustable internal door. Side tracks of the inner drivecannula (176), if present, fit inside correspondingly shaped side guidetracks of the outer cannula (148). Track and guide tracks should bedesigned to fit together such that the track fits longitudinally intothe guide track and allows longitudinal movement of the inner drivecannula within the outer cannula while limiting rotational movementbetween the inner drive cannula and the outer cannula. The proximalinner drive cannula insertion tab (FIG. 4 ELEMENT 254) of the doorconnectors (FIG. 8 b ELEMENT 108) is generally inserted into the hingehole (154) of the inner drive cannula. The shaft of the door connector(FIG. 4. ELEMENT 250) connects the hinge hole (154) of the innercatheter and door hinge hole (152). This door connector comprises ashaft (FIG. 4. ELEMENT 250) that fits and preferably moves withoutbinding within the space distal end of the adjustable device deliverysystem. To facilitate free fit and movement of the door connectors, thedoor hinge and the adjustable internal door, the inner drive cannula andouter cannula can optionally contain cut-away elements, for example, theoptional cutaway portion of the distal inner drive cannula (172) and ofthe outer cannula (158).

The superior edge of the adjustable internal door (202) in a 90 degreeposition is shown in FIG. 9 d. In this example, the geometry of thissuperior edge corresponds exactly to the geometry of the interiorsuperior surface of the outer cannula and therefore does not collidewith the outer cannula.

FIG. 9 e is a top right view of the adjustable device delivery systemwith a box indicating the location of a cut-away view shown in FIG. 9 f.FIG. 9 f is similar to FIG. 9 d except that the adjustable internal dooris shown at an open, 0 degree position. This figure is shown todemonstrate that there preferably is no internal collision between amedical device, non-medical device or EMR placed down the barrel of theadjustable device delivery system when the adjustable internal door isin an open position.

Drive Assembly

FIG. 10 a shows a top right hidden-line view of the outer cannula cover,or handle. This exemplary outer cannula cover is a cylindrical tube butcan assume any shape. The interior tract (270) has a diameter thatcorresponds to the outer diameter of the outer cannula and can bethreaded so that it can be screwed onto the proximal end of the outercannula. Alternatively, the outer cannula cover can be bonded to theproximal surface of the outer cannula using and adhesive, for example,epoxy. The proximal end of the outer cannula cover (274) can lie flushwith the proximal end of the outer cannula (FIG. 7; ELEMENT 180) or liein a position proximal or distal to the proximal end of the outercannula. Preferably, the proximal end of the outer cannula cover liesflush to the proximal end of the outer cannula. The distal edge (272) ofthe outer cannula cover can assume any shape, and, in this example, ittapers. The proximal end of the outer cannula can include a raised ridgein relation to the diameter of the outer cannula of no outer cannulacover is used. If an outer cannula cover is used, the outer cannularaised ridge can have a smaller or larger radius than the proximal endof the outer cannula cover, but it is preferably of a larger diameterthan the outer cannula cover (294). The side view in FIG. 10 c bestexemplifies an exemplary side ridge elevation. This ridge can serve as astop for use with a steering system. FIG. 10 b is a front, distal viewof an outer cannula cover.

FIG. 10 d illustrates an exemplary washer that can be placed between theinterfaces between the steering assembly and the drive actuator. Theinner diameter of this washer, the washer inner-hole diameter, cancorrespond to the diameter of the drive barrel (FIG. 2 b ELEMENT 166) ifthe drive barrel is of a smaller diameter than the drive shaft. In analternate embodiment where the drive actuator drive shaft is of asmaller diameter than the drive barrel, the washer inner-hole diametercan correspond to the diameter of the drive shaft. One or more of thesewashers can be used. Where two washers are utilized, the proximal washercan lie flush to the proximal surface (FIG. 2 b ELEMENT 162) defined bythe differential radii of the drive shaft and drive barrel and thedistal washer can lie flush to distal surface (FIG. 2 b ELEMENT 164)defined by the differential radii of the drive shaft and drive barrel.Alternatively, no washers can be used. FIG. 10 e shows a washer that canbe placed between the raised ridge of the outer cannula (FIG. 10 aELEMENT 274) and the steering system (FIG. 11 f; 120).

FIG. 11 a is a top right view of the outer cannula (146), inner drivecannula (140) and outer cannula cover (112), with a box indicating theitems that are shown in detail in FIG. 11 b. Item (274) is an outercannula raised ridge. The proximal end of the outer cannula (FIG. 7ELEMENT 180) and the proximal face of the outer cannula cover (274), ifpresent, preferably lie flush at location (290). A portion of the innerdrive cannula shaft (140), i.e., the drive actuator, itself comprising adrive barrel (166) and drive shaft (142) and, optionally one or morewashers, extends proximally from the proximal end of the outer cannula.Optionally, one or more intermediate elements can between the driveactuator and the inner drive cannula.

FIG. 11 c is a top view of the outer cannula (146), inner drive cannula(140), and outer cannula cover (112), with a box illustrating the itemsthat are shown in detail in FIG. 11 d. FIG. 11 d is a right sidehidden-line view of an outer cannula, an inner drive cannula, and outercannula cover. The locations of the optional washers (114) aredemonstrated flush to the proximal (162) and distal (164) surfaces ofthe drive shaft (142). Alternatively, the drive shaft can be of asmaller diameter than the drive barrel. Washers, if included in such anembodiment, could still be placed flush to the proximal and distalsurfaces of the drive shaft. An optional washer (116) is shown buttingagainst, or resting against in contact with, the outer cannula and outercannula cover with the distal face of the washer flush to the proximalface of the outer cannula and outer cannula cover (274).

Steering Assembly

FIG. 11 e is a side view of the outer cannula (146), inner drive cannula(140), outer cannula cover (112), optional washers (114, 116), and a cutaway side view of the steering assembly (120) with a box indicating thearea shown in detail in FIG. 11 f. FIG. 11 f shows an exemplaryalignment of a cutaway portion of the steering assembly (120) and itsinteraction with the drive actuator. A drive barrel (166) fits into acenter shaft (284) in the steering system, which is cut out and extendsthe length of the steering assembly. Optional washers (114), which arealigned with the proximal and distal faces of the drive shaft (142),each fit into cylindrical slots (280) in the steering assembly. Thesewashers are comprised of a circular element, with an outside diameter,and a circular hole in the middle defining a washer inner-hole diameter.The washer inner-hole diameter is sized to fit over the steeringactuator cylindrical drive barrel or drive shaft, depending on which islarger as described above. Where washers are not used, the cylindricalslots in the steering assembly need not be present.

An outer cannula cover washer (116) can fit into another slot (282). Thediameter of the drive shaft (142) fits into the cylindrical cutout areaof the steering apparatus (286). A cylindrical steering system cut outarea (288) in the distal portion of the steering system fits thediameter of the outer cannula cover (294) if such cover is used. Whereno outer cannula cover or outer cannula cover washer is used, the slot(282) will fit a raised ridge on the proximal end of the outer cannula,and the cylindrical steering system cut out area (288) in the distalportion of the steering system fits the diameter of the outer cannula.In either type of embodiment, the outer cannula or outer cannula covercan be threaded, and the distal end of the steering assembly can becorrespondingly threaded, wherein the longitudinal motion of thesteering assembly can be controlled by turning the steering assemblyclockwise and counter-clockwise. The steering assembly itself can becomprised of one or more pieces.

The steering assembly and the drive actuator, and hence the inner drivecannula, move together along the longitudinal axis of the adjustabledevice delivery system due to the close fit of the steering assembly andthe drive actuator as exemplified in FIG. 11 f and FIG. 11 g. Thesteering assembly can move longitudinally with respect to the outercannula due, in this figure, to the correspondingly threaded surfaces ofthe outer cannula cover and the steering assembly. Thus, rotationalmovement of the steering assembly translates into longitudinal movementof the steering assembly with respect to the outer cannula. Due to theclose connectivity of the steering assembly and the drive actuator,longitudinal movement of the steering assembly translates intolongitudinal movement of the drive actuator. As the drive actuator, inthis exemplary embodiment, comprises the proximal end of the inner drivecannula, the longitudinal movement of the drive actuator generatesequivalent longitudinal movement in the inner drive cannula.

In other embodiments, the drive actuator does not directly comprise theproximal end of the inner drive cannula but can interact with the innerdrive cannula indirectly, through one or more intermediate elements. Forexample, the drive actuator and inner drive cannula can interact througha set of gears to increase or decrease the longitudinal movement of thesteering assembly or through a compressible member, like an elastomer,to elastically transmit the longitudinal force of the steering assemblyto the adjustable internal door at the distal end of the inner drivecannula. Movement of the inner drive cannula then translates intorotational movement of the adjustable internal door, the door rotatingalong the axle axis, via its connection to the door with one or moredoor connectors.

In addition, more traditional wire or ribbon-based systems, similar tothose used to steer steerable catheter systems (for example, see U.S.Pat. No. 6,530,914), are contemplated for door movement. For example,one or more manipulation members can attach to the side surfaces of theadjustable internal door, which members can run proximally from theadjustable internal door, through the lumen of the adjustable devicedelivery system to the proximal end, where the user can adjust the angleof the door by exerting pulling or pushing forces on the manipulationmember. Alternatively, the one or more manipulation member can reside inone or more lumen separate from the lumen through which the medicaldevice, non-medical device or EMR is delivered.

Still further, embodiments that utilize one or more inflatable members,such as a balloon, for door movement are contemplated. For example, aballoon with a first and second attachment surface can attached to theadjustable device delivery system of the invention, the first attachmentsurface connected to the distal face of the adjustable internal door andthe second attachment surface connected to the distal end of the outercannula opposite the slot. The balloon can inflatably move the door froman open position (i.e., door body parallel to the longitudinal axis ofthe outer cannula) to a closed position (i.e., door body perpendicularto the longitudinal axis of the outer cannula) through inflation anddeflation of the balloon. The balloon can be inflated and deflated byone or more inflators/deflators, for example, air pumps, fluid pumps,syringes, and the like, that can reside within or, preferably, withoutthe adjustable device delivery system of the invention. The one or moreinflators/deflators can attach to the one or more inflatable membersthrough one or more inflation/deflation connectors, whichinflation/deflation connectors can run proximally from the one or moreinflatable members, through the lumen of the adjustable device deliverysystem to the proximal end, or where the one or more inflators/deflatorsreside, where the user can adjust the angle of the door by inflating ordeflating the one or more inflatable members utilizing the one or moreinflators/deflators. Alternatively, the one or more inflation/deflationconnectors can connect the inflatable member to the one or moreinflators/deflators through one or more lumen separate from the lumenthrough which the medical device, non-medical device or EMR isdelivered.

FIG. 12 a is a top right view of the adjustable device delivery systemwith the box indicating the area, which is shown in detail in FIG. 12 b.FIG. 12 b is a top right hidden-line view of a complete exemplarysteering assembly. The steering shaft (284) can be the same diameter asthe drive barrel of the inner drive cannula (FIG. 11 f ELEMENT 166). Thecut-out area (FIG. 11 f ELEMENT 286) allows the assembly to fit over thedrive shaft (FIG. 11 f ELEMENT 142). A cylindrical steering system cutout area (288) fits over the shaft of the outer cannula cover (FIG. 11 fELEMENT 294), if used, or over the outer cannula if no outer cannulacover is used. The cylindrical slots (280) that accommodate the washers(FIG. 11 f ELEMENT 114) that are flush with the drive shaft (FIG. 11 fELEMENT 142) are demonstrated. Another slot (282) that can accommodate awasher (FIG. 11 f ELEMENT 116) that can lie flush with the outercatheter cover (FIG. 11 f ELEMENT 294), if used, or over the outercannula if no outer cannula cover is used, is also demonstrated.

The steering assembly is free to rotate clockwise and counter-clockwisearound the longitudinal axis of the adjustable device delivery system.The distal portion of the steering assembly (288), which is preferablyof a complementary size to the surfaces of the outer cannula cover(294), if used, or the outer cannula, is preferably threaded to matchthreads on the outer cannula cover or outer cannula. Consequently,rotational motion of the steering assembly translates into proximal anddistal translation of the steering assembly in relation to the outercannula cover and/or outer cannula. Because the inner drive cannula isfixed in relative position with the drive actuator, the drive actuatorand inner drive cannula move longitudinally along with the steeringassembly. The drive actuator and inner drive cannula can be directlyconnected, the drive actuator comprising the proximal end of the innerdrive cannula, or, as mentioned above, the drive actuator can beindirectly associated with the inner drive cannula. Washers, if present,preferably prevent unwanted torque between the inner and outer cannulas.

FIG. 12 c is a top right view of the adjustable device delivery systemwith the box indicating the area that is shown in detail in FIG. 12 d.In embodiments that comprise complementary-threaded surfaces on theouter cannula or outer cannula cover and the steering assembly allow forthe longitudinal movement of the drive actuator, inner drive cannula andadjustable internal door by rotating the steering assembly in either aclockwise or counter-clockwise direction depending on the configurationof the threaded surfaces. When an outer cannula cover is present, theouter cannula is generally fixed inside the outer cannula cover. Theinner drive cannula, and associated drive actuator, is fixed in relativeposition to the steering assembly. Therefore, proximal motion of thesteering assembly causes proximal motion of the inner drive cannula inrelation to the outer cannula. Continued proximal motion ultimatelycauses the adjustable internal door to be pulled closed to angleapproaching, and in some embodiments surpassing, 90 degrees. Once again,in embodiments where clockwise rotation of the steering assemblytranslates into distal movement of the adjustable internal door,counter-clockwise rotation will result in proximal translation of theadjustable internal door. Controlled longitudinal movement can beaccomplished in some embodiments that lack threaded surfaces on theouter cannula or outer cannula cover and the steering assembly. Forexample, a friction-based mechanism can control longitudinal motion ofthe drive actuator, inner drive cannula and internal adjustable door.

FIG. 12 e and FIG. 12 f illustrate an exemplary lock system and steeringassembly showing possible relative position of the steering assembly tothe lock assembly. In this example, an outer cannula cover is present.FIG. 12 e demonstrates the relative positions of a lock system and asteering assembly when the adjustable device delivery system has anadjustable internal door open at about 0 degrees. When the adjustableinternal door is open, the inner drive cannula is located at its mostdistal position in relation to the outer drive cannula. This openposition for the adjustable internal door allows maximum space (402)inside the steering apparatus (120) between the distal end of thesteering assembly slot (FIG. 11 f; ELEMENT 282) and the proximal end ofthe outer cannula and/or outer cannula cover. The open position alsoyields a smaller amount of space (400) between the steering apparatus(120) and lock apparatus (122). In contrast, when the adjustableinternal door is to be closed to any angle, the inner drive cannula mustmove in a proximal direction in relation to the outer cannula. Rotationof the steering assembly in a clockwise or counter-clockwise direction,again depending on the orientation or polarity of the threads, can movethe steering assembly proximally, away from the distal end of the outercannula. Such movement increases the distance (400) between the steeringassembly (120) and the lock system (122). Closing the adjustableinternal door (i.e., changing the angle of the door to about 90 degreesin relation to the longitudinal axis of the adjustable device deliverysystem), allows minimum space (402) inside the steering apparatus (120)between the distal end of the steering assembly slot (FIG. 11 f; ELEMENT282) and the proximal end of the outer cannula and/or outer cannulacover. In alternate embodiments, the steering assembly and the locksystem can interact with the outer surface of the outer cannula or, ifpresent, the outer surface of an outer cannula cover, in a non-threadedmanner. For example, the lock could operate with a simple friction fitwherein the lock system moves on the outer cannula or outer cannulacover with resistance, such that moving the lock adjacent to or abuttingthe steering assembly provides resistance to steering assembly movement.

Lock Motion

FIG. 12 g is similar to FIG. 12 f in that it illustrates the adjustabledevice delivery system with the adjustable internal door closed to amaximum angle with attention placed on the steering assembly (120) andlocking system (122). The steering assembly is unlocked in FIG. 12 g.When the lock is moved proximally, or to the left in this Figure, itultimately collides with the steering assembly and locks it in place,preventing movement of the steering assembly (FIG. 12 h). Unlocking theapparatus is achieved by moving the locking system distally so that itis no longer in contact with the steering assembly, thus freeing thesteering assembly for movement of the adjustable internal door. Again,the lock can be moved via threads on the outer cannula or outer cannulacover and complementary threads on the interior surface of the locksystem, or by other methods such as friction fit, as described above.

Outer Cannula Cover

A box illustrates the location of the optional outer cannula cover andseparate handle in relation to the adjustable device delivery system inFIG. 13 a. When present, an outer cannula cover can act as a handle forthe user. When not present, the surface of the outer cannula can serveas a handle for the use. FIG. 13 b shows a handle separate from an outercannula cover. The inner circumference of the handle should correspondto the outer diameter of the outer cannula cover (FIG. 10 a, ELEMENT294). A separate handle can be attached as described above, namely witha threaded interior surface that complements a correspondingly threadedouter surface of an outer cannula cover or, for example, with anadhesive like epoxy.

Lock

FIG. 14 a shows the adjustable device delivery system with a box aroundthe lock system. FIG. 14 b is a face view of the lock system. Theapparatus can be, for example, a hexagonal nut with beveled edges. Theinner circumference of the lock system preferably has an inner diameterthat corresponds to the outer diameter of the outer cannula cover (FIG.10 a, ELEMENT 294), if present, or the outer diameter of the outercannula. The interior surface of the lock system and outer cannula orouter cannula cover can be complementarily threaded so that the lock canrotate clockwise and counter-clockwise in relation to the outer cannulacover, if present, or the outer cannula, locking and unlocking thesteering assembly accordingly.

DESCRIPTION OF PREFERRED USES

The adjustable device delivery system has many applications inbiological or medical fields. Uses in interventional radiology andendovascular surgery include: creation of arterial/venous fistula,stenting of arteries and veins which are located at angles, includingright angles, angioplasty at angles, including right angles, anddrainage of various collections. The adjustable device delivery systemsof the invention would also advance and facilitate existing techniquesof TIPS (transjugular intrahepatic portosystemic shunt). Uses forcardiologists include the angled placement of pacing wires, angioplastyof vessels, formation of fistulas, and stenting of the coronary sinusinto the left ventricle. Urologic uses include prostate biopsy, drainageof collections along the urethra as well as biopsy and manipulation oflow-lying bladder lesions difficult to reach with traditional devices.Colorectal uses include the drainage of ischiorectal abscesses as wellas drainage and or/biopsy of other collections located along thegastrointestinal tract that could not be easily achieved by colonoscopy.Gastrology uses for the device include transgastric drainage ofcollections such as pancreatic pseudocysts as well as other collectionsalong the GI tract. Pulmonologists could use the device to aid biopsyduring bronchoscopy. Additional uses for the devices of the inventionnot explicitly recited herein will be evident to those having skill inthis art.

The adjustable device delivery systems of the invention are not usefulonly for deflecting stents and needles but also have the ability todeflect electromagnetic waves used in visualization devices. Theseelectromagnetic waves could represent acoustic, optic, or otherradiation devices used to visualize a target. For these uses, theinvention provides embodiments of the devices disclosed herein having anadjustable internal door that is either be made of any combination ofcorresponding reflective materials or coated with such materials.

An example of such an embodiment is placement of an intravascularultrasound device down the barrel of the adjustable device deliverysystem (170). The operator advances the distal tip of the visualizationdevice (304) to a point just proximal to the axle of the adjustableinternal door (260). The acoustic waves projected from the tip of theultrasound (306) bounce off of the proximal reflective surface of theadjustable internal door (212) at the desired angle set by the operator.The electromagnetic waves returning from the target are deflected by theadjustable internal door as well back into the tip of the visualizationdevice.

Thus, the adjustable device delivery system can function as avisualization control system for technology placed down its lumen. Thereflective surface of the adjustable internal door does not need to belimited to acoustic devices such as ultrasound. In other embodiments,the adjustable internal door can be coated with an optical reflectivesurface such as a mirror. Reflective surfaces can be combined whennecessary and adapted to new forms of radiation visualizationtechnology.

The reflective surface of the adjustable internal door does not have tobe limited to visualization technology. Any device that relies onelectromagnetic radiation can be deflected with the adjustable internaldoor; examples include laser and radiation devices used to cut andcoagulate tissue. In further embodiments, the surface of the adjustableinternal door can be shaped in such a manner as to facilitate focusingof these various forms of electromagnetic radiation.

The adjustable device delivery system can also be used to perform tissuebiopsies at user-defined and adjustable angles to aid in various formsof cancer diagnosis and treatment. An example is the use of theadjustable device delivery system to perform prostate biopsy. After lungcancer, prostate cancer accounts for more cancer deaths in men than anyother cancer. The prostate lies at a right angle to the prostaticurethra. Although existing devices can be passed up and into theurethra, the angle of the prostate makes an adequate transurethralbiopsy difficult. By providing a method to perform visualization andinstrumentation, or the delivery of devices, at various, user-definedangles, the adjustable device delivery system can be advantageouslyused.

The use of the present invention to perform a less invasive form ofcancer biopsy may increase the likelihood that males seek both screeningand diagnostic procedures. The potential for increased biopsy accuracywith the present invention can allow for a higher percentage of accuratetumor samples. Increased biopsy accuracy would decrease the need forrepeat procedures and, consequently, speed the time to diagnosis anddefinitive treatment.

Moreover, the use of the device deflection system could be used incombination with existing cancer treatments. Lasers or various forms ofradiation or other energy sources can be deflected off the door atadjustable angles. Tumor cells are thus fulgurated and/or ablated in amore controlled manner with less damage to surrounding healthy tissue.Protection of healthy tissue around the prostate is paramount given thenumber of surrounding nerves and vital structures. The possibilities ofmore accurate and efficient therapies might decrease impotence and otherdebilitating side-effects from current treatments for the more advancedstages of prostate cancer.

These examples refer to just some of the applications of the adjustabledevice delivery system; these examples are not intended to be limiting,and those with skill in the art would recognize multiple otherpossibilities and uses for this device. For example, the device could beplaced down the lumen of a tube with a camera passed down the barrel ofthe instrument, and the camera would permit direct visualization as theinstrument was placed into position. Alternatively, a device such as acolonoscope could be passed down the barrel of a larger version of thedevice. The operator controlling the inserting colonoscope would alsocontrol the path of the adjustable device delivery system. Therefore,once the colonoscope indicated that the device was in proper position,the colonoscope could be removed and instrumentation could follow.

Embodiments wherein the door is located at the distal end of the outercannula and wherein said door extends beyond the distal end of the outercannula when in its open position (i.e., the door is parallel to thelongitudinal axis of the outer cannula), are particularly well suited tobe used as a steering device for placement of, for example, a guidewire.That is, the catheter delivery system can not only be used to deliver adevice (here, a guidewire) at a user-defined angle, as describedelsewhere herein, but a guidewire delivered at a user defined angle canthen be used to steer adjustable device delivery system itself along theguidewire path. For example, the adjustable device delivery system canbe placed in, for example, a blood vessel lumen, and a guidewire can beadvanced through the lumen of the adjustable device delivery system anddeflected at a user-defined angle to a target area. After the guidewirehas been delivered to (or toward) a target area, the adjustable devicedelivery system can then be advanced along the length of the guidewire.That is, the adjustable device delivery system of the invention is usedto steer a guidewire in a particular direction through deflection of theguidewire off of the adjustable internal door at a user-defined angle.The adjustable device delivery system is then advanced along theuser-defined path of the guidewire to a new position. This process canbe repeated as necessary, and such iterative, repeated placement of theguidewire at user-defined angles and similar advances of the devicedelivery system along the path of the guidewire effectively steers theguidewire and adjustable device delivery system along any user-definedpath, for example, through a maze of blood vessels, such as is found ininterventional cardiology. Placement of the adjustable internal door atthe distal end of the outer cannula wherein the door extends beyond thedistal end of the outer cannula when in its open position facilitatessteering of the adjustable device delivery system due to a lack ofextraneous outer cannula distal to the adjustable internal door thatcould hinder advancement along the guidewire in confined spaces. Theadjustable internal door can be in an open, closed or intermediateposition while advancing the adjustable device delivery system along aguidewire.

The adjustable device delivery system of this invention is also relevantin non-biological procedures. For example, the adjustable devicedelivery system of the invention would function to deliver a device toan area of limited access, for example, to place a wire or pipe at anangle in a narrow space. Such uses make the present invention important,inter alia, in automobile assembly as well as other mechanized assemblylines.

With respect to the above uses for the adjustable device deliverysystems of the invention, the outer cannula is designed in closerelation to the inner drive cannula, the geometry of the outer cannulagenerally comprising a cylindrical tube with a radius that is determinedby the size of the device being delivered. For example, if constructionfor angioplasty is desired, a suitable size for the outer cannula wouldbe approximately 7F, or 7 French. For other uses, such as, for example,device delivery in the gastrointestinal system or in non-medical pipesor conduits, a much larger size can potentially be used. The outercannula and inner drive cannula can be made of any suitable materialwhether rigid or flexible.

One application of the use of the devices of the invention, specificallyas operated in blood vessels is as follows. A small incision is made inthe skin or a vessel located and entered percutaneously. A guidewire isplaced down a vessel lumen. The incision is expanded using dilators sothat adjustable device delivery system could be slid down the guidewirewith the adjustable internal door in the open position. The adjustabledevice delivery system and its adjustable internal door is slid to theestimated desired position guided by external or internal visualizationtechniques including fluoroscopy and ultrasound.

Once the adjustable device delivery system is placed in the correctlocation, the guidewire is withdrawn. An intravascular ultrasound orother imaging device is fed down the lumen of the adjustable devicedelivery system with the adjustable internal door in the open position.When, for example, the distal tip of the intravascular ultrasoundapproached the adjustable internal door, the operator turns the handleof the steering assembly in the proper direction to close the adjustableinternal door to the desired angle.

Once the adjustable internal door is closed to the desired degree andthe target collection or vessel is identified by the distal tip of theintravascular ultrasound, the operator then locks the angle of theadjustable internal door with the lock system, for example, by buttingthe lock system against the steering assembly so that the steeringassembly cannot move.

The intravascular ultrasound or visualizing apparatus is then removed.The operator then slides the desired medical or non-medical device downthe adjustable device delivery system. Because the adjustable internaldoor has been locked in position and because of the difficulties inovercoming the inherent frictional forces in the steering assembly, theadjustable internal door preferably does not move between instrumentchanges. When the medical device reaches the door, it is deflected atthe same angle previously selected by intravascular ultrasound orexternal visualization techniques.

Another advantageous use for the devices of the invention is for guidinga needle meant to penetrate a cavity located at an angle to a vessel orlumen housing the adjustable device delivery system. When the needlehits the door, it is deflected at the desired angle. The needle path isvisualized by external techniques such as fluoroscopy or internaltechniques if, in this example, the needle and a visualization devicelike an intravascular ultrasound can both be delivered to the area ofinterest simultaneously. When the needle penetrates the desired lumen orspace, further devices can be delivered with the adjustable internaldoor in the same locked position.

A drainage catheter can then be slid in standard Seldinger technique sothat it follows the same pathway as the needle and enters the same lumenor space. The needle could then be withdrawn.

The adjustable device delivery system is then unlocked by moving thelocking mechanism away from the steering assembly. The adjustableinternal door is opened by turning the steering mechanism in theopposite direction of that described above to close the adjustableinternal door. Such movement of the steering assembly causes theinternal drive cannula to be pushed distally into the outer cannula,whereupon the one or more door connectors would push on the adjustableinternal door until it swung distally and was once again in an open 0degree position.

The catheter is then removed from the body by pulling the entireapparatus proximally. No external collision between the angled stent andthe body of the adjustable device delivery system occurs because of thecut-away slot in the distal portion of the outer cannula that extends tothe distal end of the outer cannula. Because the adjustable internaldoor was fully opened before removal of the device delivery system, andconsequently was not in the pathway of the stent, there is no collisionbetween the adjustable device delivery system and the stent, whichallows the stent to retain its angle of delivery.

Methods

The invention also provides methods for delivering a medical device, anon-medical device, including without limitation those described above,or EMR to an confined space. Such methods can be accomplished byinserting the adjustable device delivery system into a confined space,for example, through an incision in a biological system. Once inserted,the adjustable device delivery system is guided to the location ofinterest, or a delivery location, in the confined space. Once inserted,the adjustable device delivery system can be oriented such that the slotin the distal end of the outer cannula faces the desired deliverylocation. The orientation step can be performed before an attempt atguiding the adjustable device delivery system to the delivery locationis made, especially if an internal visualization device is used to guidethe delivery system. The adjustable internal door is then adjusted to auser-defined angle for delivery of the visualization or other device.One or a plurality of medical devices, non-medical devices or EMR canthen be delivered to the delivery location through the lumen of theadjustable device delivery system tubular body in a proximal to distaldirection, wherein the device is deflected off of the adjustableinternal door at about the user-defined angle of the adjustable internaldoor. Once delivered, the device is utilized in its conventional mannerat the delivery location. This method can optionally comprise the stepof removing the device delivery system from the confined space with thedevice remaining within the confined space or removing the device fromthe confined space along with the device delivery system.

The invention also provides methods for deploying one or a plurality ofmedical devices at a user-defined angle. Such methods can beaccomplished by inserting an adjustable device delivery system of theinvention into a space that is connected or proximal to a location wherethe user desires to deliver the medical device, or medical devicedelivery location. Once inserted, the adjustable device delivery systemis guided to the medical device delivery location within or proximal tothe space. Once inserted, the adjustable device delivery system can beoriented such that the slot in the distal end of the outer cannula facesthe desired direction of medical device deployment. The orientation stepcan performed before an attempt at guiding the adjustable devicedelivery system to the medical device delivery location is made,especially if an internal visualization device is used to guide thedelivery system. The adjustable internal door is then adjusted to auser-defined angle for delivery of the medical device, which is thendelivered to the delivery location through the lumen of the adjustabledevice delivery system tubular body in a proximal to distal direction,such that the medical device is deflected off of the adjustable internaldoor at about the user-defined angle of the adjustable internal door.The medical device is then utilized in its intended manner at themedical device delivery location, for example, a intravascularultrasound is used for visualization or catheter is used to drain anabscess. These methods of the invention can further comprise the step ofremoving the device delivery system from the medical device deliverylocation leaving the medical device behind within the delivery location.In such a medical device delivery method, the angle of delivery of themedical device is not altered due to presence of the slot in the distalportion of the tubular body through which the medical device can slideduring removal of the device delivery system.

The invention also provides methods for forming a pathway between bodilycompartments. Such methods comprise the step of inserting the adjustabledevice delivery system of the invention into a first space that isproximal to a second space into which the pathway is to be formed. Theadjustable device delivery system is then guided to a bodily compartmentconnection location within the first space, that is, the location wherethe connection between the two body compartments is to be made. Onceinserted, the adjustable device delivery system can be oriented suchthat the slot in the distal end of the outer cannula faces the bodilycompartment connection location. The orientation step can be performedbefore the step of guiding the adjustable device delivery system to thebodily compartment connection location, especially if an internalvisualization device is used to guide the delivery system. Theadjustable internal door is then adjusted to a user-defined angle fordelivery of a device that can form a pathway between bodilycompartments. Said device is then delivered to the bodily compartmentconnection location through the lumen of the tubular body of theadjustable device delivery system in a proximal to distal direction,wherein the device is deflected off the adjustable internal door at theuser-defined angle of the adjustable internal door. Once delivered, thedevice that can form a pathway between bodily compartments is used toform the pathway between bodily compartments.

The invention also provides methods for visualization in an confinedspace. Such methods are accomplished by inserting an adjustable devicedelivery system of the invention, particularly one with an adjustableinternal door made from or coated with a material reflective for variousforms of EMR, into the confined space. Once inserted, the adjustabledevice delivery system is guided to a visualization location, or thelocation the user wishes to visualize using the methods of theinvention, in the confined space. Once positioned at the visualizationlocation, the adjustable device delivery system is oriented such thatthe slot in the distal end of the outer cannula faces the desiredvisualization location. The orientation step can be performed before theadjustable device delivery system is guided to the visualizationlocation. The adjustable internal door is then adjusted by moving thedevice in a proximal-to-distal direction from the adjustable devicedelivery system to the visualization location (and, optionally, backfrom the visualization location in a distal-to-proximal directionthrough the device delivery system) to a user-defined angle to permitdeflection of electromagnetic radiation. The EMR can then be deliveredin a proximal-to-distal direction from the adjustable device deliverysystem to the visualization location such that the electromagneticradiation is deflected off of the adjustable internal door at theuser-defined angle of the adjustable internal door. These methods ofthis aspect of the invention can further comprise the step of detectingelectromagnetic radiation deflected off of the adjustable internal doorin the opposite direction as during EMR emission, wherein suchelectromagnetic radiation moves in a distal-to-proximal direction in theadjustable device delivery system.

The invention also provides methods for delivering focusedelectromagnetic radiation in a confined space. Such methods can beaccomplished by inserting an adjustable device delivery system whereinthe adjustable internal door can deflect electromagnetic radiation intothe confined space. Once inserted, the adjustable device delivery systemhaving a reflective door is guided to an electromagnetic radiationtarget location in the confined space, and the adjustable devicedelivery system is oriented such that the slot in the distal end of theouter cannula faces the desired electromagnetic radiation targetlocation. The orientation step can be performed before the adjustabledevice delivery system is guided to the visualization location Theadjustable internal door is then adjusted to a user-defined angle bymoving the device in a proximal-to-distal direction from the adjustabledevice delivery system, thereby permitting delivery of focused ofelectromagnetic radiation to the electromagnetic radiation targetlocation. Finally, the EMR is delivered in a proximal-to-distaldirection from the adjustable device delivery system to theelectromagnetic radiation target location such that the electromagneticradiation is focused by the adjustable internal door and deflected atthe user-defined angle of the adjustable internal door to theelectromagnetic radiation target location.

In all of the above aspects of the invention, the device delivered bythe adjustable device delivery system can be a medical or non-medicaldevice. Further, the location to which a medical or non-medical deviceis delivered can be in a biological or non-biological system.

The following Examples are provided for the purposes of illustration andare not intended to limit the scope of the present invention. Thepresent invention is not to be limited in scope by the exemplifiedembodiments, which are intended as illustrations of individual aspectsof the invention. Indeed, various modifications of the invention inaddition to those shown and described herein will become apparent tothose skilled in the art from the foregoing description and accompanyingdrawings. Such modifications are intended to fall within the scope ofthe appended claims.

EXAMPLE 1

FIGS. 15 a through 15 m outline the use of the device for placement of astent between two neighboring blood vessels. In each of FIGS. 15 athrough 15 m, element 302 is the outline of the entry vessel down whichthe adjustable device delivery system is percutaneously delivered andelement 304 represents a target vessel.

FIG. 15 a demonstrates the native position of these two vessels. Aguidewire can be percutaneously placed down a target vessel using, forexample, techniques of external visualization like fluoroscopy. FIG. 15b shows such a guidewire (300) passing down the lumen of the entryvessel (302) in close proximity to the target vessel (304).

The adjustable device delivery system is inserted through an introducersheath into the entry vessel. An operator would preferably have theadjustable internal door (104) in the open position, at an angle ofabout 0 degrees, with the locked applied if present. Maintaining theadjustable internal door in the open position ensures a straightpassageway of the adjustable device delivery system down the guidewirefollowing, for example, standard Seldinger technique. Externalvisualization can be used to place the instrument until the axle of theadjustable internal door (260) is located in close proximity to thedesired exit point for the entry vessel (302) and entry point for targetvessel (304), or the bodily compartment connection location. The entireinstrument is rotated so that the external slit of the outer cannula(130) faces the target area. The guidewire is then removed with theinstrument remaining in the desired location such as demonstrated inFIG. 15 d.

FIG. 15 e demonstrates the adjustable device delivery system in the sameposition as in FIG. 15 d. An instrument such as an intravascularultrasound (308) has been passed down the barrel of the catheter. Theadjustable device delivery system would be typically, but notnecessarily, advanced under external visualization, such as fluoroscopy,so that the distal tip of the intravascular ultrasound would beoverlying the adjustable internal door.

FIG. 15 f demonstrates how the operator would use the steering apparatuson the adjustable device delivery system to adjust the angle of theadjustable internal door. The visual field of the ultrasound (306), andoptionally combined with an external visualization technique such asfluoroscopy, would allow the operator to adjust the distal angle andfield of view of the ultrasound (306) until the adjustable internal doorwas in the exact position desired. At this point the operator would lockthe position of the door by rotating the lock system until the proximalface of the lock surface was flush with, i.e., butted against, thedistal face of the steering apparatus. The resulting frictional forcesbetween the lock system and the steering assembly would prevent unwantedmotion of the steering system and, hence, the adjustable internal doorduring device exchanges and general use of the adjustable devicedelivery system.

FIG. 15 h demonstrates the adjustable device delivery system in the sameposition after the intravascular ultrasound has been removed. Because ofthe inherent frictional forces of the steering assembly on the outercannula or outer cannula cover, if present, and because of theadditional frictional forces achieved by application of the lock, theadjustable internal door preferably does not move in between instrumentchanges. The adjustable internal door therefore remains in the sameposition as was previously determined by using internal visualizationtechniques and, optionally, external visualization techniques inconjunction with the intravascular ultrasound.

An operator is then able to slide another medical device down the barrelof the adjustable device delivery system such as a needle (310). Becausethe adjustable internal door is locked in position, the operator couldexert sufficient force on the needle and the proximal face of theadjustable internal door to achieve adequate deflection and controlledperforation of vessel lumen and surrounding structures. This techniquewould be performed under careful external visualization or concomitantinternal visualization, the internal visualization device beingdelivered through the lumen of the adjustable device delivery systemalong with other devices such as the needle (310). When the needle wasin the proper structure, the operator would then have the opportunityfor further instrumentation. An example of further instrumentationincludes the placement of, for example, a drainage catheter. Theoperator could slide such a drainage catheter (312) over the needle withthe adjustable device delivery system and the adjustable internal doorin the same position. Such an operation is shown in FIG. 15 j.

After both the needle and the catheter were determined to be in properposition, the operator then removes the needle. This leaves theadjustable internal door in the same locked position with the catheterin the same position, and the adjustable device delivery system in thesame position. This is demonstrated in FIG. 15 k.

The operator then unlocks the adjustable internal door by releasing thelock system. Releasing the lock system causes the lock system totranslate distally (toward the distal end of the outer cannula) so thatthe distal face of the steering assembly would no longer collide withthe proximal face of the lock system. Consequently, the operator is ableto turn the steering apparatus such that the drive actuator, inner drivecannula and adjustable internal door moves distally, pushing theadjustable internal door back down to its open position at 0 degrees.The described positions of the adjustable internal door and adjustabledevice delivery system position are demonstrated in FIG. 15 l.

FIG. 15 m demonstrates the adjustable device delivery system beingremoved from the body by pulling in the proximal direction (to the leftin the illustration). This Figure demonstrates the final placement ofthe drainage catheter (312) as well as the adjustable device deliverysystem's unobstructed removal. That is, the adjustable device deliverysystem can be removed, through the combination of the slot in the distalportion of the outer cannula and the adjustable internal door, withoutdisturbing a delivered device, such as the drainage catheter (312),including, even, the angle at which it was delivered. Thus, unlike othersystems in the art, there is no internal collision between theadjustable device delivery system of the invention and the delivereddevice because the adjustable internal door (104) can retract to anopen, 0 degree position. Further, because the exterior slit of theexterior catheter (130) extends to the distal extent of the outercannula (182), there is no external collision between the external wallof the adjustable device delivery system and the drainage catheter.

It should be understood that the foregoing disclosure emphasizes certainspecific embodiments of the invention and that all modifications oralternatives equivalent thereto are within the spirit and scope of theinvention as set forth in the appended claims.

1. An adjustable device delivery system comprising: a tubular bodyhaving a proximal end, a distal end, a longitudinal axis, a lumenextending within the tubular body, and a slot within the tubular bodyextending to and including its distal end; and an adjustable internaldoor comprising a door body with a superior, inferior, proximal, distaland two side surfaces, at least one door hinge hole in the side surfacesof the door body and a door hinge surface on the inferior surface of thedoor body, the adjustable internal door hingedly coupled to the interiorof the tubular body, located opposite the slot in the distal portion ofthe tubular body.
 2. The adjustable device delivery system of claim 1wherein at least one device is slidably connected within the lumen ofthe tubular body, wherein the at least one device is deflected off ofthe proximal surface of the adjustable internal door at a user-definableangle and delivered to a target site at the user-definable angle.
 3. Theadjustable device delivery system of claim 2, wherein the tubular bodycomprises an outer cannula and an inner drive cannula, wherein the innerdrive cannula is slidably connected to the inside of the outer cannula.4. The adjustable device delivery system of claim 3, wherein the distalend of the outer cannula is open.
 5. The adjustable device deliverysystem of claim 3, wherein the distal end of the outer cannula containsa slot extending to and including its distal end.
 6. The adjustabledevice delivery system of claim 5, wherein the slot in the distal end ofthe outer cannula comprises about 50 percent of the circumference of theouter cannula.
 7. The adjustable device delivery system of claim 5,wherein the slot in the distal end of the outer cannula comprises lessthan 50 percent of the circumference of the outer cannula.
 8. Theadjustable device delivery system of claim 5, wherein the slot in thedistal end of the outer cannula comprises more than 50 percent of thecircumference of the outer cannula.
 9. The adjustable device deliverysystem of claim 5, wherein the slot in the distal end of the outercannula extends about 3 door-lengths from the distal end of the outercannula.
 10. The adjustable device delivery system of claim 5, whereinthe slot in the distal end of the outer cannula extends more than 3door-lengths from the distal end of the outer cannula.
 11. Theadjustable device delivery system of claim 5, wherein the slot in thedistal end of the outer cannula extends less than 3 door-lengths fromthe distal end of the outer cannula.
 12. The adjustable device deliverysystem of claim 3, wherein the distal portion of the inner drive cannulacomprises an open shaft.
 13. The adjustable device delivery system ofclaim 12, wherein the shape of the distal portion of the inner drivecannula that comprises an open shaft approximates the lower portion of ahalf cylinder.
 14. The adjustable device delivery system of claim 3,wherein the proximal portion of the inner drive cannula comprises adrive actuator to move the inner drive cannula along the longitudinalaxis.
 15. The adjustable device delivery system of claim 14, wherein thedrive actuator comprises a drive barrel at the proximal end of the innerdrive cannula and a drive shaft of a different diameter than the drivebarrel located within the axial length of the drive barrel, wherein theedges defined by the different radial distances at the drivebarrel-drive shaft interface provide a leverage means to move the innerdrive cannula along the longitudinal axis.
 16. The adjustable devicedelivery system of claim 15, wherein the drive actuator comprises adrive barrel of a smaller diameter than the drive shaft.
 17. Theadjustable device delivery system of claim 15, wherein the driveactuator comprises a drive barrel of a larger diameter than the driveshaft.
 18. The adjustable device delivery system of claim 15, whereinthe drive actuator further comprises at least one washer wherein thewasher inner-hole diameter is larger than the smaller of the drivebarrel diameter or drive shaft diameter but smaller than the larger ofthe drive barrel diameter or drive shaft diameter wherein the at leastone washer resides on the smaller diameter drive barrel or drive shaftand press against the larger diameter drive barrel or drive shaft tomove the inner drive cannula along the longitudinal axis.
 19. Theadjustable device delivery system of claim 16, wherein the driveactuator further comprises at least one washer wherein the washerinner-hole diameter is larger than the drive barrel diameter but smallerthan the drive shaft diameter wherein the at least one washer resides onthe drive barrel and press against the drive shaft to move the innerdrive cannula along the longitudinal axis.
 20. The adjustable devicedelivery system of claim 18 wherein the drive actuator further comprisesat least one washer wherein the washer inner-hole diameter is largerthan the drive shaft diameter but smaller than the drive barrel diameterwherein the at least one washer resides on the drive shaft and pressagainst the drive barrel to move the inner drive cannula along thelongitudinal axis.
 21. The adjustable device delivery system of claim15, 16, 17, 18, 19 or 20, wherein the drive barrel and drive shaft arecylindrical.
 22. The adjustable device delivery system of claim 3,wherein the outer cannula contains an axle shell in its distal end. 23.The adjustable device delivery system of claim 14, wherein the outercannula contains an axle shell in its distal end.
 25. The adjustabledevice delivery system of claim 22, wherein the axle shell is locatedopposite the slot in the outer cannula.
 26. The adjustable devicedelivery system of claim 23, wherein the axle shell is located oppositethe slot in the outer cannula.
 27. The adjustable device delivery systemof claim 22, wherein the axle shell holds on its inner surfaces an axlecomprising a middle portion and two cylindrical side portions, whereinthe outer diameter of the cylindrical side portions of the axlecorresponds to the inner diameter of the axle shell, and the size andgeometric shape of the middle portion of the axle is the same as ordifferent from the cylindrical side portions of the axle.
 28. Theadjustable device delivery system of claim 23, wherein the axle shellholds on its inner surfaces an axle comprising a middle portion and twocylindrical side portions, wherein the outer diameter of the cylindricalside portions of the axle corresponds to the inner diameter of the axleshell, and the size and geometric shape of the middle portion of theaxle is the same as or different from the cylindrical side portions ofthe axle.
 29. The adjustable device delivery system of claim 27, whereinthe door hinge surface of the adjustable internal door is hingedlycoupled to the middle portion of the axle wherein the size and geometricshape of the middle portion of the axle corresponds to the geometricsize and shape of the inner surface of the door hinge surface.
 30. Theadjustable device delivery system of claim 28, wherein the door hingesurface of the adjustable internal door is hingedly coupled to themiddle portion of the axle wherein the size and geometric shape of themiddle portion of the axle corresponds to the geometric size and shapeof the inner surface of the door hinge surface.
 31. The adjustabledevice delivery system of claim 29, further comprising a door connectorsystem moveably connecting the distal end of the inner drive cannula atleast one hinge hole to the door hinge holes in the side surfaces of thedoor body of the adjustable internal door.
 32. The adjustable devicedelivery system of claim 30, further comprising a door connector systemmoveably connecting the distal end of the inner drive cannula at leastone hinge hole to the door hinge holes in the side surfaces of the doorbody of the adjustable internal door.
 33. The adjustable device deliverysystem of claim 31 or 32, wherein the door connector system comprises atleast one door connector comprising a shaft with a proximal and a distalend, the proximal end comprising a proximal inner drive cannulainsertion tab, which is moveably connected to the hinge hole in thedistal end of the inner drive cannula and the distal end comprising adistal door insertion tab, which is moveably connected to the door hingehole in the side surface of the door body.
 34. The adjustable devicedelivery system of claim 31 or 32, wherein proximal movement of theinner drive cannula pulls on the door connectors at the proximal innerdrive cannula insertion tab and translates the proximal movement up theshaft to the distal door insertion tab to the door hinge holes on theside surface of the adjustable internal door to the door body itself,which hingedly moves on the axle, increasing the angle of the adjustableinternal door within the distal end of the outer cannula.
 35. Theadjustable device delivery system of claim 33, wherein distal movementof the inner drive cannula pushes on the door connectors at the proximalinner drive cannula insertion tab and translates the proximal movementup the shaft to the distal door insertion tab to the door hinge holes onthe side surface of the adjustable internal door to the door bodyitself, which hingedly moves on the axle, decreasing the angle of theadjustable internal door within the distal end of the outer cannula. 36.The adjustable device delivery system of claim 3, wherein the distalportion of the outer cannula and the distal portion of the inner drivecannula contain at least one cut away region wherein the adjustableinternal door and hinge move longitudinally.
 37. The adjustable devicedelivery system of claim 3, wherein the inner drive cannula is slidablyconnected to the inside of the outer cannula on a track system.
 38. Theadjustable device delivery system of claim 14, wherein the inner drivecannula is slidably connected to the inside of the outer cannula on atrack system.
 39. The adjustable device delivery system of claim 37 or38, wherein the track system comprises an outer cannula that contains atleast one guide track and an inner drive cannula that contains at leastone corresponding track upon which the inner drive cannula slidablymoves on the longitudinal axis.
 40. The adjustable device deliverysystem of claim 39, wherein the track system comprises an outer cannulathat contains at least one side guide tracks and at least one bottomguide track and an inner drive cannula that contains at least onecorresponding side track and at least one corresponding bottom trackupon which the inner drive cannula slidably moves on the longitudinalaxis.
 41. The adjustable device delivery system of claim 39, wherein thetrack system comprises an outer cannula that contains at least one sideguide track and an inner drive cannula that contains at least onecorresponding side track upon which the inner drive cannula slidablymoves on the longitudinal axis.
 42. The adjustable device deliverysystem of claim 39, wherein the track system comprises an outer cannulathat contains at least one bottom guide track and an inner drive cannulathat contains at least one corresponding bottom track upon which theinner drive cannula slidably moves on the longitudinal axis.
 43. Theadjustable device delivery system of claim 14, wherein the proximalportion of the outer cannula is threaded to facilitate the rotatableattachment of at least one correspondingly threaded attachment.
 44. Theadjustable device delivery system of claim 15, wherein the proximalportion of the outer cannula is threaded to facilitate the rotatableattachment of at least one correspondingly threaded attachment.
 45. Theadjustable device delivery system of claim 16, wherein the proximalportion of the outer cannula is threaded to facilitate the rotatableattachment of at least one correspondingly threaded attachment.
 46. Theadjustable device delivery system of claim 17, wherein the proximalportion of the outer cannula is threaded to facilitate the rotatableattachment of at least one correspondingly threaded attachment.
 47. Theadjustable device delivery system of claim 18, wherein the proximalportion of the outer cannula is threaded to facilitate the rotatableattachment of at least one correspondingly threaded attachment.
 48. Theadjustable device delivery system of claim 19, wherein the proximalportion of the outer cannula is threaded to facilitate the rotatableattachment of at least one correspondingly threaded attachment.
 49. Theadjustable device delivery system of claim 20, wherein the proximalportion of the outer cannula is threaded to facilitate the rotatableattachment of at least one correspondingly threaded attachment.
 50. Theadjustable device delivery system of claim 43, 44, 45, 46, 47, 48 or 49,wherein the proximal end of the outer cannula optionally includes araised ridge of a larger diameter than the proximal end of the outercannula.
 51. The adjustable device delivery system of claim 43, 44, 47or 49, wherein the attachment comprises a steering assembly comprising acenter shaft, two or more cylindrical cutout areas wherein the outerdiameter of the drive actuator drive barrel fits within the innerdiameter of the steering assembly center shaft, which shaft is cut outand extends the longitudinal length of the steering assembly, acylindrical cutout area in the distal end of the steering assembly of aninner diameter corresponding to the outer diameter of the proximalportion of the threaded outer cannula, the cylindrical cutoutcorrespondingly threaded to rotatably attach to the proximal end of theouter cannula enabling longitudinal movement of the steering system, acylindrical cutout area of an inner diameter corresponding to the outerdiameter of the drive actuator drive shaft and a longitudinal lengthwherein the cylindrical cutout can fit over a drive actuator drive shaftof larger diameter than the drive actuator drive barrel or within adetent created when the drive actuator drive shaft diameter is smallerthan the drive actuator drive barrel, wherein the surfaces of thesteering assembly correspond to the surfaces of the drive actuator andthe outer cannula, the steering assembly can freely rotate around thelongitudinal axes of the drive actuator and the rotational motion of thesteering assembly translates into proximal and distal translation of thesteering assembly in relation to the outer cannula.
 52. The adjustabledevice delivery system of claim 44, 45, 46, 47, 48 or 49, wherein theattachment comprises a steering assembly comprising a center shaft, twoor more cylindrical cutout areas wherein the outer diameter of the driveactuator drive barrel fits into the inner diameter of the steeringassembly center shaft, which shaft is cut out and extends thelongitudinal length of the steering assembly, a cylindrical cutout areain the distal end of the steering assembly of an inner diametercorresponding to the outer diameter of the proximal portion of thethreaded outer cannula, the cylindrical cutout correspondingly threadedto rotatably attach to the proximal end of the outer cannula enablinglongitudinal movement of the steering system, a cylindrical cutout areaof an inner diameter corresponding to the outer diameter of the driveactuator drive shaft and a longitudinal length wherein the cylindricalcutout can fit over a drive actuator drive shaft of larger diameter thanthe drive actuator drive barrel or within a detent created when thedrive actuator drive shaft diameter is smaller than the drive actuatordrive barrel, wherein the surfaces of the steering assembly correspondto the surfaces of the drive actuator and the outer cannula, thesteering assembly can freely rotate around the longitudinal axes of thedrive actuator and the rotational motion of the steering assemblytranslates into proximal and distal translation of the steering assemblyin relation to the outer cannula.
 53. The adjustable device deliverysystem of claim 51, further comprising at least one cylindrical slot ofcorresponding diameter and longitudinal position within the steeringassembly to interact with at least one washer present at the proximalend of the outer cannula and at the diametrically differing interfacesbetween the drive barrel and drive shaft.
 54. The adjustable devicedelivery system of claim 52, further comprising at least one cylindricalslot of corresponding diameter and longitudinal position within thesteering assembly to interact with at least one washer present at theproximal end of the outer cannula and at the diametrically differinginterfaces between the drive barrel and drive shaft.
 55. The adjustabledevice delivery system of claim 43, 44, 47 or 49, further comprising alock system comprising an inner surface and an outer surface, the innersurface of a diameter corresponding to the outer diameter of theproximal end of the outer cannula and threaded to facilitate itsrotatable attachment to the correspondingly threaded proximal end of theouter cannula.
 56. The adjustable device delivery system of claim 44,45, 46, 47, 48 or 49, further comprising a lock system comprising aninner surface and an outer surface, the inner surface of a diametercorresponding to the outer diameter of the proximal end of the outercannula and threaded to facilitate its rotatable attachment to thecorrespondingly threaded proximal end of the outer cannula.
 57. Theadjustable device delivery system of claim 51, further comprising a locksystem comprising an inner surface and an outer surface, the innersurface of a diameter corresponding to the outer diameter of theproximal end of the outer cannula and threaded to facilitate itsrotatable attachment to the correspondingly threaded proximal end of theouter cannula.
 58. The adjustable device delivery system of claim 52,further comprising a lock system comprising an inner surface and anouter surface, the inner surface of a diameter corresponding to theouter diameter of the proximal end of the outer cannula and threaded tofacilitate its rotatable attachment to the correspondingly threadedproximal end of the outer cannula.
 59. The adjustable device deliverysystem of claim 57, wherein the lock system locks the position of thesteering assembly, drive actuator, inner drive cannula and adjustableinternal door by rotatably butting against the steering assembly on thethreads of the outer cannula preventing the movement of the steeringassembly, drive actuator, inner drive cannula and adjustable internaldoor.
 60. The adjustable device delivery system of claim 57, wherein thelock system unlocks the position of the steering assembly, driveactuator, inner drive cannula and adjustable internal door by rotatablymoving away from the steering assembly on the threads of the outercannula enabling the movement of the steering assembly, drive actuator,inner drive cannula and adjustable internal door.
 61. The adjustabledevice delivery system of claim 58, wherein the lock system locks theposition of the steering assembly, drive actuator, inner drive cannulaand adjustable internal door by rotatably butting against the steeringassembly on the threads of the outer cannula preventing the movement ofthe steering assembly, drive actuator, inner drive cannula andadjustable internal door.
 62. The adjustable device delivery system ofclaim 58, wherein the lock system unlocks the position of the steeringassembly, drive actuator, inner drive cannula and adjustable internaldoor by rotatably moving away from the steering assembly on the threadsof the outer cannula enabling the movement of the steering assembly,drive actuator, inner drive cannula and adjustable internal door. 63.The adjustable device delivery system of claim 14, further comprising anouter cannula cover that contains an interior tract, wherein thediameter of the outer cannula cover interior tract corresponds to theouter diameter of the outer cannula and the outer cannula cover isattached to the proximal end of the outer cannula, the outer cannularesiding within the interior tract of the outer cannula cover, andwherein the distal portion of the outer cannula cover can serve as ahandle for operation of the adjustable delivery system.
 64. Theadjustable device delivery system of claim 15, further comprising anouter cannula cover that contains an interior tract, wherein thediameter of the outer cannula cover interior tract corresponds to theouter diameter of the outer cannula and the outer cannula cover isattached to the proximal end of the outer cannula, the outer cannularesiding within the interior tract of the outer cannula cover, andwherein the distal portion of the outer cannula cover can serve as ahandle for operation of the adjustable delivery system.
 65. Theadjustable device delivery system of claim 15, wherein the driveactuator comprises a drive barrel of a smaller diameter than the driveshaft, and further comprising an outer cannula cover that contains aninterior tract, wherein the diameter of the outer cannula cover interiortract corresponds to the outer diameter of the outer cannula and theouter cannula cover is attached to the proximal end of the outercannula, the outer cannula residing within the interior tract of theouter cannula cover, and wherein the distal portion of the outer cannulacover can serve as a handle for operation of the adjustable deliverysystem.
 66. The adjustable device delivery system of claim 15, whereinthe drive actuator comprises a drive barrel of a larger diameter thanthe drive shaft, and further comprising an outer cannula cover thatcontains an interior tract, wherein the diameter of the outer cannulacover interior tract corresponds to the outer diameter of the outercannula and the outer cannula cover is attached to the proximal end ofthe outer cannula, the outer cannula residing within the interior tractof the outer cannula cover, and wherein the distal portion of the outercannula cover can serve as a handle for operation of the adjustabledelivery system.
 67. The adjustable device delivery system of claim 18,further comprising an outer cannula cover that contains an interiortract, wherein the diameter of the outer cannula cover interior tractcorresponds to the outer diameter of the outer cannula and the outercannula cover is attached to the proximal end of the outer cannula, theouter cannula residing within the interior tract of the outer cannulacover, and wherein the distal portion of the outer cannula cover canserve as a handle for operation of the adjustable delivery system. 68.The adjustable device delivery system of claim 19, further comprising anouter cannula cover that contains an interior tract, wherein thediameter of the outer cannula cover interior tract corresponds to theouter diameter of the outer cannula and the outer cannula cover isattached to the proximal end of the outer cannula, the outer cannularesiding within the interior tract of the outer cannula cover, andwherein the distal portion of the outer cannula cover can serve as ahandle for operation of the adjustable delivery system.
 69. Theadjustable device delivery system of claim 20, further comprising anouter cannula cover that contains an interior tract, wherein thediameter of the outer cannula cover interior tract corresponds to theouter diameter of the outer cannula and the outer cannula cover isattached to the proximal end of the outer cannula, the outer cannularesiding within the interior tract of the outer cannula cover, andwherein the distal portion of the outer cannula cover can serve as ahandle for operation of the adjustable delivery system.
 70. Theadjustable device delivery system of claim 63, wherein the proximalportion of the interior tract of the outer cannula cover is threaded torotatably attach to an outer cannula that is correspondingly threaded atits proximal end.
 71. The adjustable device delivery system of claim 63,wherein the outer cannula cover is bonded to the proximal end of theouter cannula, the outer cannula residing within the interior tract ofthe outer cannula cover.
 72. The adjustable device delivery system ofclaim 71, wherein the outer cannula cover is bonded with an adhesive.73. The adjustable device delivery system of claim 63, wherein theexterior of the proximal portion of the outer cannula cover is threadedto facilitate the rotatable attachment of correspondingly threadedattachments.
 74. The adjustable device delivery system of claim 64, 65,66, 67, 68 or 69, wherein the exterior of the proximal portion of theouter cannula cover is threaded to facilitate the rotatable attachmentof correspondingly threaded attachments.
 75. The adjustable devicedelivery system of claim 73, wherein the proximal end of the outercannula can include a raised ridge of a larger diameter than theproximal end of the outer cannula.
 76. The adjustable device deliverysystem of claim 74, wherein the proximal end of the outer cannula caninclude a raised ridge of a larger diameter than the proximal end of theouter cannula.
 77. The adjustable device delivery system of claim 75,wherein the raised ridge is of a diameter equivalent to or larger thanthe proximal end of the outer cannula cover.
 78. The adjustable devicedelivery system of claim 76, wherein the raised ridge is of a diameterequivalent to or larger than the proximal end of the outer cannulacover.
 79. The adjustable device delivery system of claim 73, whereinthe attachment comprises a steering assembly comprising a center shaft,two or more cylindrical cutout areas wherein the outer diameter of thedrive actuator drive barrel fits into the inner diameter of the steeringassembly center shaft, which shaft is cut out and extends thelongitudinal length of the steering assembly, a cylindrical cutout areain the distal end of the steering assembly of an inner diametercorresponding to the outer diameter of the proximal portion of thethreaded outer cannula cover, the cylindrical cutout correspondinglythreaded to rotatably attach to the proximal end of the outer cannulacover enabling longitudinal movement of the steering system, acylindrical cutout area of an inner diameter corresponding to the outerdiameter of the drive actuator drive shaft and a longitudinal lengthwherein the cylindrical cutout can fit over a drive actuator drive shaftof larger diameter than the drive actuator drive barrel or within adetent created when the drive actuator drive shaft diameter is smallerthan the drive actuator drive barrel, wherein the surfaces of thesteering assembly correspond to the surfaces of the drive actuator andthe outer cannula cover, the steering assembly can freely rotate aroundthe longitudinal axes of the drive actuator and the rotational motion ofthe steering assembly translates into proximal and distal translation ofthe steering assembly in relation to the outer cannula.
 80. Theadjustable device delivery system of claim 74, wherein the attachmentcomprises a steering assembly comprising a center shaft, two or morecylindrical cutout areas wherein the outer diameter of the driveactuator drive barrel fits into the inner diameter of the steeringassembly center shaft, which shaft is cut out and extends thelongitudinal length of the steering assembly, a cylindrical cutout areain the distal end of the steering assembly of an inner diametercorresponding to the outer diameter of the proximal portion of thethreaded outer cannula cover, the cylindrical cutout correspondinglythreaded to rotatably attach to the proximal end of the outer cannulacover enabling longitudinal movement of the steering system, acylindrical cutout area of an inner diameter corresponding to the outerdiameter of the drive actuator drive shaft and a longitudinal lengthwherein the cylindrical cutout can fit over a drive actuator drive shaftof larger diameter than the drive actuator drive barrel or within adetent created when the drive actuator drive shaft diameter is smallerthan the drive actuator drive barrel, wherein the surfaces of thesteering assembly correspond to the surfaces of the drive actuator andthe outer cannula cover, the steering assembly can freely rotate aroundthe longitudinal axes of the drive actuator and the rotational motion ofthe steering assembly translates into proximal and distal translation ofthe steering assembly in relation to the outer cannula.
 81. Theadjustable device delivery system of claim 79, further comprising atleast one cylindrical slot of corresponding diameter and longitudinalposition within the steering assembly to interact with at least onewasher present at the proximal end of the outer cannula and outercannula cover and at the diametrically differing interfaces between thedrive barrel and drive shaft.
 82. The adjustable device delivery systemof claim 80, further comprising at least one cylindrical slot ofcorresponding diameter and longitudinal position within the steeringassembly to interact with at least one washer present at the proximalend of the outer cannula and outer cannula cover and at thediametrically differing interfaces between the drive barrel and driveshaft.
 83. The adjustable device delivery system of claim 73, furthercomprising a lock system comprising an inner surface and an outersurface, the inner surface of a diameter corresponding to the outerdiameter of the proximal end of the outer cannula cover and threaded tofacilitate its rotatable attachment to the correspondingly threadedproximal end of the outer cannula cover.
 84. The adjustable devicedelivery system of claim 74, further comprising a lock system comprisingan inner surface and an outer surface, the inner surface of a diametercorresponding to the outer diameter of the proximal end of the outercannula cover and threaded to facilitate its rotatable attachment to thecorrespondingly threaded proximal end of the outer cannula cover. 85.The adjustable device delivery system of claim 79, further comprising alock system comprising an inner surface and an outer surface, the innersurface of a diameter corresponding to the outer diameter of theproximal end of the outer cannula cover and threaded to facilitate itsrotatable attachment to the correspondingly threaded proximal end of theouter cannula cover.
 86. The adjustable device delivery system of claim80, further comprising a lock system comprising an inner surface and anouter surface, the inner surface of a diameter corresponding to theouter diameter of the proximal end of the outer cannula cover andthreaded to facilitate its rotatable attachment to the correspondinglythreaded proximal end of the outer cannula cover.
 87. The adjustabledevice delivery system of claim 85, wherein the lock system locks theposition of the steering assembly, drive actuator, inner drive cannulaand adjustable internal door by rotatably butting against the steeringassembly on the threads of the outer cannula cover preventing themovement of the steering assembly, drive actuator, inner drive cannulaand adjustable internal door.
 88. The adjustable device delivery systemof claim 86, wherein the lock system locks the position of the steeringassembly, drive actuator, inner drive cannula and adjustable internaldoor by rotatably butting against the steering assembly on the threadsof the outer cannula cover preventing the movement of the steeringassembly, drive actuator, inner drive cannula and adjustable internaldoor.
 89. The adjustable device delivery system of claim 85, wherein thelock system unlocks the position of the steering assembly, driveactuator, inner drive cannula and adjustable internal door by rotatablymoving away from the steering assembly on the threads of the outercannula cover enabling the movement of the steering assembly, driveactuator, inner drive cannula and adjustable internal door.
 90. Theadjustable device delivery system of claim 86, wherein the lock systemunlocks the position of the steering assembly, drive actuator, innerdrive cannula and adjustable internal door by rotatably moving away fromthe steering assembly on the threads of the outer cannula cover enablingthe movement of the steering assembly, drive actuator, inner drivecannula and adjustable internal door.
 91. The adjustable device deliverysystem of claim 75, wherein the raised ridge acts as a physical stop forthe steering assembly.
 92. The adjustable device delivery system ofclaim 76, wherein the raised ridge acts as a physical stop for thesteering assembly.
 93. The adjustable device delivery system of claim 1,2, 3, 14, 22, 23, 31, 32, 37, 37, 43, 51, 55, 57, 63, 73, 79, 83 or 85,wherein the device is a medical device.
 94. The adjustable devicedelivery system of claim 1, 2, 3, 14, 22, 23, 31, 32, 37, 37, 43, 51,55, 57, 63, 73, 79, 83 or 85, wherein the device is a non-medicaldevice.
 95. The adjustable device delivery system of claim 1, whereinthe adjustable internal door deflects electromagnetic radiation.
 96. Theadjustable device delivery system of claim 95, further comprising ameans for detecting electromagnetic radiation deflected by theadjustable internal door, the radiation moving in a distal-to-proximaldirection in the adjustable device delivery system.
 97. The adjustabledevice delivery system of claim 1, wherein the adjustable internal doorcan focus electromagnetic radiation.
 98. The adjustable device deliverysystem of claim 97, further comprising a means for detectingelectromagnetic radiation focused by the adjustable internal door, theradiation moving in a distal-to-proximal direction in the adjustabledevice delivery system.
 99. The adjustable device delivery system ofclaim 1 or 2 wherein the tubular body is flexible.
 100. The adjustabledevice delivery system of claim 3, wherein the inner drive cannula andouter cannula are flexible.
 101. An apparatus for delivering a device toconfined space comprising: a) a tubular body having a proximal end, adistal end, a longitudinal axis, a lumen extending within the tubularbody, and a slot within the tubular body extending to and including itsdistal end; b) an adjustable internal door hingedly coupled to theinterior of the tubular body opposite the slot extending to andincluding its distal end; and c) means for a user to change the angle ofthe adjustable internal door relative to the longitudinal axis of thetubular body so that a device delivered through the lumen of the tubularbody is deflected out of the lumen at the user-defined angle of theadjustable internal door, through the slot in the tubular body.
 102. Theapparatus of claim 101, further comprising a means for fixing theadjustable internal door at the user-defined angle.
 103. The apparatusof claim 101 or 102 wherein the tubular body is flexible.
 104. A methodof delivering a device to an confined space comprising: inserting theadjustable device delivery system of claim 1, into the confined space;guiding the adjustable device delivery system to a delivery location inthe confined space for the device to be deployed; orienting theadjustable device delivery system wherein the slot in the distal end ofthe outer cannula faces the desired delivery location; adjusting theadjustable internal door to a user-defined angle for delivery of thedevice; and delivering the device to the delivery location through thelumen of the adjustable device delivery system tubular body in aproximal to distal direction wherein the device is deflected off of theadjustable internal door at about the user-defined angle of theadjustable internal door.
 105. The method of claim 104, furthercomprising the step of removing the device delivery system from theconfined space with the device remaining within the confined space. 106.The method of claim 104, further comprising the step of removing thedevice from the confined space with the device delivery system.
 107. Themethod of claim 104, wherein the device is a medical device.
 108. Themethod of claim 104, wherein the device is a non-medical device.
 109. Amethod of deploying a medical device at a user-defined angle comprising:inserting the adjustable device delivery system of claim 1, into a spacethat is connected or proximal to a medical device delivery location;guiding the adjustable device delivery system to the medical devicedelivery location within or proximal to the space; orienting theadjustable device delivery system wherein the slot in the distal end ofthe outer cannula faces the desired direction of medical devicedeployment; adjusting the adjustable internal door to a user-definedangle for delivery of the medical device; and delivering the medicaldevice to the delivery location through the lumen of the adjustabledevice delivery system tubular body in a proximal to distal directionwherein the medical device is deflected off of the adjustable internaldoor at about the user-defined angle of the adjustable internal door.110. The method of claim 109, further comprising the step of removingthe device delivery system from the medical device delivery locationwith the medical device remaining within the delivery location whereinthe angle of delivery of the medical device is not altered due topresence of the slot in the distal portion of the tubular body throughwhich the medical device can slide during removal of the device deliverysystem.
 111. A method of forming a pathway between bodily compartmentscomprising: inserting the adjustable device delivery system of claim 1,into a first space that is proximal to a second space into which thepathway is to be formed; guiding the adjustable device delivery systemto a bodily compartment connection location within the first space;orienting the adjustable device delivery system wherein the slot in thedistal end of the outer cannula faces the bodily compartment connectionlocation; adjusting the adjustable internal door to a user-defined anglefor delivery of a device that can form a pathway between bodilycompartments; delivering the device that can form a pathway betweenbodily compartments to the bodily compartment connection locationthrough the lumen of the adjustable device delivery system tubular bodyin a proximal to distal direction wherein the device is deflected off ofthe adjustable internal door at about the user-defined angle of theadjustable internal door; and forming the pathway between bodilycompartments.
 112. A method of visualization in an confined spacecomprising: inserting the adjustable device delivery system of claim 97,into the confined space; guiding the adjustable device delivery systemto a visualization location in the confined space; orienting theadjustable device delivery system wherein the slot in the distal end ofthe outer cannula faces the desired visualization location; adjustingthe adjustable internal door to a user-defined angle to enabledeflection of electromagnetic radiation moving in a proximal-to-distaldirection from the adjustable device delivery system to thevisualization location and, optionally, back from the visualizationlocation in a distal-to-proximal direction through the device deliverysystem; and delivering the electromagnetic radiation in aproximal-to-distal direction from the adjustable device delivery systemto the visualization location wherein the electromagnetic radiation isdeflected off of the adjustable internal door at the user-defined angleof the adjustable internal door.
 113. The method of claim 112, furthercomprising detecting electromagnetic radiation deflected off of theadjustable internal door, such electromagnetic radiation moving in adistal-to-proximal direction in the adjustable device delivery system.114. A method of delivering focused electromagnetic radiation in anconfined space comprising: inserting the adjustable device deliverysystem of claim 97, into the confined space; guiding the adjustabledevice delivery system to an electromagnetic radiation target locationin the confined space; orienting the adjustable device delivery systemwherein the slot in the distal end of the outer cannula faces thedesired electromagnetic radiation target location; adjusting theadjustable internal door to a user-defined angle to enable delivery offocused of electromagnetic radiation moving in a proximal-to-distaldirection from the adjustable device delivery system to theelectromagnetic radiation target location; and delivering theelectromagnetic radiation in a proximal-to-distal direction from theadjustable device delivery system to the electromagnetic radiationtarget location wherein the electromagnetic radiation is focused by theadjustable internal door and deflected at the user-defined angle of theadjustable internal door.
 115. A method of steering a device within aconfined space comprising: inserting the adjustable device deliverysystem of claim 99 into the confined space; guiding the adjustabledevice delivery system to a first delivery location in the confinedspace for the device to be deployed; orienting the adjustable devicedelivery system wherein the slot in the distal end of the outer cannulafaces the first delivery location; adjusting the adjustable internaldoor to a user-defined angle for delivery of the device; delivering thedevice to the first delivery location through the lumen of theadjustable device delivery system tubular body in a proximal to distaldirection wherein the device is deflected off of the adjustable internaldoor at about the user-defined angle of the adjustable internal door;advancing the adjustable device delivery system along the path ofdelivered device to the first delivery location orienting the adjustabledevice delivery system wherein the slot in the distal end of the outercannula faces a second delivery location; adjusting the adjustableinternal door to a user-defined angle for delivery of the device; anddelivering the device to the second delivery location through the lumenof the adjustable device delivery system tubular body in a proximal todistal direction wherein the device is deflected off of the adjustableinternal door at about the user-defined angle of the adjustable internaldoor.
 116. A method of steering an adjustable device delivery systemwithin a confined space comprising: inserting the adjustable devicedelivery system of claim 99 into the confined space; guiding theadjustable device delivery system to a first delivery location in theconfined space for the device to be deployed; orienting the adjustabledevice delivery system wherein the slot in the distal end of the outercannula faces the first delivery location; adjusting the adjustableinternal door to a user-defined angle for delivery of the device;delivering the device to the first delivery location through the lumenof the adjustable device delivery system tubular body in a proximal todistal direction wherein the device is deflected off of the adjustableinternal door at about the user-defined angle of the adjustable internaldoor; advancing the adjustable device delivery system along the path ofdelivered device to the first delivery location; guiding the adjustabledevice delivery system to a second delivery location in the confinedspace for the object to be deployed; orienting the adjustable devicedelivery system wherein the slot in the distal end of the outer cannulafaces the second delivery location; adjusting the adjustable internaldoor to a user-defined angle for delivery of the device; delivering thedevice to the second delivery location through the lumen of theadjustable device delivery system tubular body in a proximal to distaldirection wherein the device is deflected off of the adjustable internaldoor at about the user-defined angle of the adjustable internal door;and advancing the adjustable device delivery system along the path ofdelivered device to the second delivery location.